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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