Recall Z-2653-2010 ยท DEW Igg, Antigen, Antiserum, Control
Beckman Coulter Inc.
SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920
| Date | Sep 30, 2010 (initiated Jun 28, 2010) |
| Status | Terminated |
| Reason | 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. |
| 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 opt |
| Quantity | 852 units |
| Distribution | US Nationwide & Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965108 | SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT Beckman Instruments, Inc., Mar 6, 1997 |