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U.S. Department of Health and Human Services

Class 2 Device Recall SYNCHRON System(s) Immunoglobulin A (IgA) Reagent

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 Class 2 Device Recall SYNCHRON System(s) Immunoglobulin A (IgA) Reagentsee related information
Date Initiated by FirmJune 28, 2010
Date PostedSeptember 30, 2010
Recall Status1 Terminated 3 on July 31, 2012
Recall NumberZ-2653-2010
Recall Event ID 56247
510(K)NumberK965108 
Product Classification Immunoglobulin A (Ig-A) Reagent - Product Code DEW
ProductSYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920
Code Information Lot Numbers: M812164, M902345
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information ContactClair K. ODonovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Other
ActionA 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.
Quantity in Commerce852 units
DistributionUS Nationwide & Canada
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DEW
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