Retiro De Equipo (Recall) de COULTER Ac"T" 5diff Fix Reagent.

Recall

58569

Class 2

Z-2231-2011

2011-04-08

2011-05-20

Terminated

United States

2012-06-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99603

The recall was initiated because beckman coulter has confirmed that an issue has been identified with one of the raw materials used to manufacture the coulter a t 5 diff pn 8547171.

Beckman Coulter initiated a Product Corrective Action (PCA) letter on April 8, 2011, with attached PCA Response Form to all customers who purchased the COULTER¿ Ac"T" 5diff Fix Reagent. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discard the product according to their laboratory safety procedures and use the attached response form to request replacement product. All flagged results should be reviewed as outlined in the Instructions for Use manual and your laboratory protocol. A retrospective review of results is not required if all recommendations for review have been followed as shown in the Instructions for Use. Customers were instructed to share the information with their laboratory staff and to retain the notification as part of their Quality System documentation. If the product was further distirbuted to another laboratory, customers should provide them a copy of the notification letter. The raw material issue has been corrected beginning with COULTER¿ A T 5diff Fix lot 16902E. Customers were instructed to complete and return the enclosed Response Form within ten (10) days. Customers with any questions concerning this notice, were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.