Device Recall SYNCHRON System(s) Immunoglobulin A (IgA) Reagent 의 리콜

Recall

56247

Class 2

Z-2653-2010

2010-06-28

2010-09-30

Terminated

United States

2012-07-31

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93055

The recall was initiated after beckman coulter inc. confirmed reports of high recovery of immunoglobulin a (iga) in proficiency surveys or patient samples using synchron ig-a reagent lots m812164 or m902345. using these reagent lots, some samples deficient in iga have yielded results in the normal range. other samples with normal levels of iga have yielded falsely high results.

A Product Corrective Action (PCA) letter was sent on the week of June 28, 2010 to the affected customers. The letter provided the customers with an explanation of the problem identified and advised customers to discontinue use of the affected lots of the SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent. Customers were instructed to: (1) Discontinue use of Ig-A reagent lots M812164 and M902345. Contact your Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or contact your local Beckman Coulter Representative to discuss reagent replacement options. (2) You may need to re-evaluate samples for IgA that were tested with either of the listed lots of Ig-A reagent. (3) Please complete and return the enclosed response form within 10 days so that we may maintain our records. Customers were also instructed to share this information with your laboratory staff and retain this notification as part of your Quality System documentation. If you have forwarded the affected products listed above to another laboratory, please provide a copy of this letter to them. If they have any questions regarding this Product Corrective Action letter, customers were told to contact our Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Requests, or call (800) 854-3633 in the United States and Canada.