Z-2653-2010

SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920

Name: Z-2653-2010 SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920
Creator: Beckman Coulter Inc.
Published: 2010-06-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-06-28 / Terminated

FDA source

Beckman Coulter Inc. began a recall of SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920 on 2010-06-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2653-2010
Status: Terminated
Initiated: 2010-06-28
Posted: 2010-09-30
Terminated: 2012-07-31
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920
Product code: DEW Igg, Antigen, Antiserum, Control
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 root cause: Other
Action: 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.
Quantity in commerce: 852 units
Distribution: US Nationwide & Canada
Product codes and lots: Lot Numbers: M812164, M902345

Product code DEW

K965108Class IISynchron Lx Systems Immunoglobulin G/a/m ReagentBeckman Instruments, Inc. / cleared 1997-03-06

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)