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Urgent Field Safety Notice
21 January 2014
Product Name:
ACE Control
Product Code:
A6040
Lot Numbers:
042, 043, 044
Component number (I-78-21)
Expiry date:
02-2016
Type of Action:
Device Modification
Dear Valued Customer,
We would like to take this opportunity to inform you that additional testing has been completed on ACE Normal
Control (product code A6040-6X1ML) as a result of a complaint investigation. The results indicate that an
adjustment to the ACE Normal Control range is required for Lots 042, 043, 044.
Upon review of the QA release testing, the range calculated at the time of kit release (done per standard
operating procedures) supports the Control range assigned upon product release, i.e. 28-52 at 37°C. However,
upon investigation of a complaint encompassing several lots of reagents, the assigned Control range has been reevaluated and it was determined that the range for these lots requires an adjustment to 23-43 at 37°C.
If you or our customers have used these ACE Normal Control lots when testing and reporting patient results, and
the results were within the assigned range (28-52 at 37°C), then the test and reported patient results were valid.
A re-evaluation of these results is not necessary and there is no risk to patient health.
Therefore we ask you to comply with the following:
• Distribute Appendix 1 (Updated Assigned Value Sheets Rev 2) to all impacted End Users
• Place Appendix 1(Updated Assigned Value Sheets Rev 2) in all remaining inventory
• Complete the attached Faxback form indicating that you have received this notification and acknowledge
this Control range adjustment.
We wish to sincerely apologize for any inconvenience caused as a result of this Urgent Field Safety Notice. Trinity
Biotech is committed to offering quality products and superior customer service. If you have any questions or
comments arising from this Urgent Field Safety Notice, please contact us at the following:
Trinity Biotech, One Southern Cross, IDA Business Park, Bray, Co. Wicklow, Ireland
Tel: +353-1-2769800 – contact Clinical Chemistry Support Team
Fax: + 353-1-2769888– contact Clinical Chemistry Support Team
e-mail: [email protected]
Sincerely,
Tracey Murphy
Head of Quality and Regulatory Affairs
Trinity Biotech
One Southern Cross
IDA Business Park
Bray, Co Wicklow
Ireland
T +353 1 276 9800
F +353 1 276 9888
[email protected]
www.trinitybiotech.com
Trinity Biotech Manufacturing Limited
Registered in Ireland. Registration number 239206
Directors: RP O’Caoimh (CEO), R Nealon, K Tansley
Urgent Field Safety Notice
FAXBACK FORM
21 January 2014
Please complete and promptly return (by e-mail or Fax) to:
Yvonne Kenny, Regulatory Affairs Department, Trinity Biotech
Email: [email protected] or Fax: + 353-1-2769888
Product Name:
ACE Control
Product Code:
A6040
Lot Numbers:
042, 043, 044
Component number (I-78-21)
Expiry date:
02-2016
Type of Action:
Device Modification
Customer Name:
Customer Address:
Dear <Name>
Further to the enclosed Urgent Field Safety Notice, you are requested to complete the following:
•
I have received and reviewed the enclosed Urgent Field Safety Notice
Yes / No
•
I have notified my customers this Urgent Field Safety Notice and provided a copy of
Appendix 1 (Updated Assigned Value Sheets Rev 2)
Yes / No
•
I have placed Appendix 1 ((Updated Assigned Value Sheets Rev 2) into all remaining
inventory
Yes / No
Printed Name: _________________________________
Signed: _____________________________
Title:
__________________________ _______
Date:
Fax:
_____________________________
Phone: _____________________________
_____________________________
Comments: _______________________________________________________________________________
_________________________________________________________________________________
Trinity Biotech
One Southern Cross
IDA Business Park
Bray, Co Wicklow
Ireland
T +353 1 276 9800
F +353 1 276 9888
[email protected]
www.trinitybiotech.com
Trinity Biotech Manufacturing Limited
Registered in Ireland. Registration number 239206
Directors: RP O’Caoimh (CEO), R Nealon, K Tansley
ACE CONTROL-N
Catalog No. A 6040
ACE CONTROL-N
Ref. A 6040
Kit Lot # 042 Rev. 2
Número de Porción 042 Rev. 2
ASSIGNED VALUES
VALORES ASIGNADOS
Comp. Lot: I-78-21
Número de porción componente: I-78-21
Exp. cad.: 2016-02
Exp. Date: 2016-02
Constituent
Assay
Temperature
Assigned
Value
Expected
Range
Constituyente
Temperatura
de ensayo
Valor
asignado
Rango
esperado
ACE
30ºC
29 U/L
20-39
ACE
30ºC
29
U/L
20-39
37ºC
33 U/L
23-43
37ºC
33
U/L
23-43
Values were assigned using Procedure No. 305-UV and may not
apply if other methods are used.
Los valores se han asignado utilizando el procedimiento Nº 305UV y pueden no ser de aplicación si se utilizan otros métodos.
CONTRÔLE ECA-N
CONTROLLO N ACE
Codice catalogo A 6040
o
Numero di lotto 042 Rev. 2
Référence n A 6040
Nombre de sort 042 Rev. 2
VALORI ASSEGNATI
VALEURS CIBLE
Nombre de sort composant: I-78-21
Date de Peremption: 2016-02
Valeur
Température
Numero di Lotto componente: I-78-21
Data di scadenza: 2016-02
Constituant
de dosage
Cible
Intervalle de
Confiance
ECA
30ºC
29 U/L
20-39
37ºC
33 U/L
23-43
Costituente
ACE
o
Ces valeurs ont été déterminées avec la méthode n 305-UV.
Ne pas en tenir compte si d’autres méthodes sont utilisées.
ACE KONTROLLE-N
Katalog-Nr. A 6040
Partienummer 042 Rev. 2
SOLLWERTE
Teilcpartienummer.: I-78-21
Verfallsdatum: 2016-02
Bestandteil
Testtemperatur
Sollwert
Sollbereich
ACE
30ºC
29 U/L
20-39
37ºC
33 U/L
23-43
Die Sollwerte wurden mit der methode Nr. 305-UV ermittelt.
Andere Methoden können abweichende Ergebnisse liefern.
Temperatura del test
Valore
assegnato
Range
atteso
30ºC
29 U/L
20-39
37ºC
33 U/L
23-43
I valori sono stati assegnati utilizzando la procedura n. 305-UV e
potrebbero non essere adatti per altri metodi.
Trinity Biotech USA
2823 Girts Road
Jamestown, NY 14702-1059
USA
Tel: 716-483-3851
Fax: 716-488-1990
P/N-A6040-29-AV
August 2011
USA Inquiries/
Renseignements pour les Etats-Unis/
Anfragen in den USA/
Información para los E.E.U.U./
Informazioni per gli USA:
Trinity Biotech USA
2823 Girts Road
Jamestown, NY USA
Tel: 1-800-325-3424
Fax: 716-487-1419
www.trinitybiotech.com
Rest of World Inquiries/
Renseignements pour les reste du
monde/
Angragen (außerhalb der USA)
Información para el resto del mundo/
Informazioni per il resto del mondo:
Trinity Biotech plc
IDA Business Park
Bray, Co. Wicklow, Ireland
Tel: 353 1 276 9800
Fax: 353 1 276 9888
ACE CONTROL-N
Catalog No. A 6040
ACE CONTROL-N
Ref. A 6040
Kit Lot # 043 Rev. 2
Número de Porción 043 Rev. 2
ASSIGNED VALUES
VALORES ASIGNADOS
Comp. Lot: I-78-21
Número de porción componente: I-78-21
Exp. cad.: 2016-02
Exp. Date: 2016-02
Constituent
Assay
Temperature
Assigned
Value
Expected
Range
Constituyente
Temperatura
de ensayo
Valor
asignado
Rango
esperado
ACE
30ºC
29 U/L
20-39
ACE
30ºC
29
U/L
20-39
37ºC
33 U/L
23-43
37ºC
33
U/L
23-43
Values were assigned using Procedure No. 305-UV and may not
apply if other methods are used.
Los valores se han asignado utilizando el procedimiento Nº 305UV y pueden no ser de aplicación si se utilizan otros métodos.
CONTRÔLE ECA-N
CONTROLLO N ACE
Codice catalogo A 6040
o
Numero di lotto 043 Rev. 2
Référence n A 6040
Nombre de sort 043 Rev. 2
VALORI ASSEGNATI
VALEURS CIBLE
Nombre de sort composant: I-78-21
Date de Peremption: 2016-02
Valeur
Température
Numero di Lotto componente: I-78-21
Data di scadenza: 2016-02
Constituant
de dosage
Cible
Intervalle de
Confiance
ECA
30ºC
29 U/L
20-39
37ºC
33 U/L
23-43
Costituente
ACE
o
Ces valeurs ont été déterminées avec la méthode n 305-UV.
Ne pas en tenir compte si d’autres méthodes sont utilisées.
ACE KONTROLLE-N
Katalog-Nr. A 6040
Partienummer 043 Rev. 2
SOLLWERTE
Teilcpartienummer.: I-78-21
Verfallsdatum: 2016-02
Bestandteil
Testtemperatur
Sollwert
Sollbereich
ACE
30ºC
29 U/L
20-39
37ºC
33 U/L
23-43
Die Sollwerte wurden mit der methode Nr. 305-UV ermittelt.
Andere Methoden können abweichende Ergebnisse liefern.
Temperatura del test
Valore
assegnato
Range
atteso
30ºC
29 U/L
20-39
37ºC
33 U/L
23-43
I valori sono stati assegnati utilizzando la procedura n. 305-UV e
potrebbero non essere adatti per altri metodi.
Trinity Biotech USA
2823 Girts Road
Jamestown, NY 14702-1059
USA
Tel: 716-483-3851
Fax: 716-488-1990
P/N-A6040-29-AV
August 2011
USA Inquiries/
Renseignements pour les Etats-Unis/
Anfragen in den USA/
Información para los E.E.U.U./
Informazioni per gli USA:
Trinity Biotech USA
2823 Girts Road
Jamestown, NY USA
Tel: 1-800-325-3424
Fax: 716-487-1419
www.trinitybiotech.com
Rest of World Inquiries/
Renseignements pour les reste du
monde/
Angragen (außerhalb der USA)
Información para el resto del mundo/
Informazioni per il resto del mondo:
Trinity Biotech plc
IDA Business Park
Bray, Co. Wicklow, Ireland
Tel: 353 1 276 9800
Fax: 353 1 276 9888
ACE CONTROL-N
Catalog No. A 6040
ACE CONTROL-N
Ref. A 6040
Kit Lot # 044 Rev. 2
Número de Porción 044 Rev. 2
ASSIGNED VALUES
VALORES ASIGNADOS
Comp. Lot: I-78-21
Número de porción componente: I-78-21
Exp. cad.: 2016-02
Exp. Date: 2016-02
Constituent
Assay
Temperature
Assigned
Value
Expected
Range
Constituyente
Temperatura
de ensayo
Valor
asignado
Rango
esperado
ACE
30ºC
29 U/L
20-39
ACE
30ºC
29
U/L
20-39
37ºC
33 U/L
23-43
37ºC
33
U/L
23-43
Values were assigned using Procedure No. 305-UV and may not
apply if other methods are used.
Los valores se han asignado utilizando el procedimiento Nº 305UV y pueden no ser de aplicación si se utilizan otros métodos.
CONTRÔLE ECA-N
CONTROLLO N ACE
Codice catalogo A 6040
o
Numero di lotto 044 Rev. 2
Référence n A 6040
Nombre de sort 044 Rev. 2
VALORI ASSEGNATI
VALEURS CIBLE
Nombre de sort composant: I-78-21
Date de Peremption: 2016-02
Valeur
Température
Numero di Lotto componente: I-78-21
Data di scadenza: 2016-02
Constituant
de dosage
Cible
Intervalle de
Confiance
ECA
30ºC
29 U/L
20-39
37ºC
33 U/L
23-43
Costituente
ACE
o
Ces valeurs ont été déterminées avec la méthode n 305-UV.
Ne pas en tenir compte si d’autres méthodes sont utilisées.
ACE KONTROLLE-N
Katalog-Nr. A 6040
Partienummer 044 Rev. 2
SOLLWERTE
Teilcpartienummer.: I-78-21
Verfallsdatum: 2016-02
Bestandteil
Testtemperatur
Sollwert
Sollbereich
ACE
30ºC
29 U/L
20-39
37ºC
33 U/L
23-43
Die Sollwerte wurden mit der methode Nr. 305-UV ermittelt.
Andere Methoden können abweichende Ergebnisse liefern.
Temperatura del test
Valore
assegnato
Range
atteso
30ºC
29 U/L
20-39
37ºC
33 U/L
23-43
I valori sono stati assegnati utilizzando la procedura n. 305-UV e
potrebbero non essere adatti per altri metodi.
Trinity Biotech USA
2823 Girts Road
Jamestown, NY 14702-1059
USA
Tel: 716-483-3851
Fax: 716-488-1990
P/N-A6040-29-AV
August 2011
USA Inquiries/
Renseignements pour les Etats-Unis/
Anfragen in den USA/
Información para los E.E.U.U./
Informazioni per gli USA:
Trinity Biotech USA
2823 Girts Road
Jamestown, NY USA
Tel: 1-800-325-3424
Fax: 716-487-1419
www.trinitybiotech.com
Rest of World Inquiries/
Renseignements pour les reste du
monde/
Angragen (außerhalb der USA)
Información para el resto del mundo/
Informazioni per il resto del mondo:
Trinity Biotech plc
IDA Business Park
Bray, Co. Wicklow, Ireland
Tel: 353 1 276 9800
Fax: 353 1 276 9888
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