Retiro De Equipo (Recall) de Device Recall SYNCHRON Systems Calibrator 1

Recall

58555

Class 2

Z-2226-2011

2011-03-11

2011-05-20

Terminated

United States

2012-05-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99589

The recall was initiated because standardization of the synchron systems calibrator 1, used for both the synchron lx and unicel dxc systems, has been established to the new ifcc reference preparation for plasma proteins, erm-da470k (formerly cr470) beginning with lot number m005558. during the standardization to the new ifcc standard, erm-da470k, we confirmed that complement c4 (c4) had been re.

Beckman Coulter initiated a Product Corrective Action (PCA) letter on the week of March 14, 2011, to the affected customers. Though Beckman is recalling the LX Cal 1, the recall letter was sent to the C4 reagent customers, as these are the only customers who will be impacted by the problem noted in the PCA letter. The letter provided the customers with an explanation of the problem identified and an action to be taken. The letter recommended consignees take the following actions: (1)Notify their clients to review and evaluate the impact on patients whose Complement C4 recovered near the clinical decision points. (2) Re-evaluate their laboratory's reference ranges for C4. The letter further requested that consignees share this information with laboratory staff and retain this notification as part of your laboratory Quality System documentation. Questions regarding this Product Announcement letter, or requests for the correlation graphs should be directed to Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Request or call (800) 854-3633 in the United States and Canada.