Retiro De Equipo (Recall) de Device Recall Coulter Lyse S III diff Lytic

Recall

58235

Class 2

Z-2213-2011

2010-12-28

2011-05-19

Terminated

United States

2012-06-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98781

The recall was initiated by beckman coulter because the coulter lyse iii diff lytic reagent lot number 101554f was released for distribution to customers between november 17 and december 1, 2010 prior to completion of qc testing.

Beckman Coulter sent a Product Corrective Action ( PCA) letter dated December 28, 2010, to all affected consignees with an attached PCA Response form via US Postal Service for US Customers) who purchased the Coulter Lyse S III diff Lytic Lot # 101554F. The letter provides customers with an explanation of the problem identified and an action to be taken. If customers currently had any of the lot mentioned above in their laboratory, they were asked to discontinue use and discard remaining product according to their laboratory chemical safety procedures. And to complete and return the enclosed response form within 10 days to acknowledge that they received this notice and are taking appropriate action. For the population at most risk, there is no serious consequences and only remote probability of injury and medically reversible consequences due by the small change for Hgb and WBC results. Consignees were also asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Technical questions regarding this Product Corrective Action were directed to Beckman Coulter Customer Service at( 800) -526-7694 in the United States and Canada.