Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
FDA device recall Z-2488-2023 · posted 2023-08-31 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Lipemic interference failed to meet the performance specification listed within the IFU.
- Action taken
- On July 18, 2023 Beckman Coulter issued a "Urgent Medical Device Recall" Notification via email and postal mail. Beckman Coulter asked consignees to take the following action: 1. No retrospective re view of past patient results is required however Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. 2. Discontinuance or disposal of this product is not necessary. 3. Per the IFU, avoid highly lipemic samples when using the IgA assay. 4. No update is required to the LIH influences check settings on the analyzer, where in use. 5. Please share this information with your laboratory staff nd retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 6. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: - Electronically - If you received this communication via email, Manually - complete and return the enclosed Response Form. 7. If you have any questions regarding this notice, please contact our Customer Support Center - www.beckmancoulter.com or 1-800-854-3633 8. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- CFN
- Quantity affected
- 12,850 units
- Distribution
- US: AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD MI MN MO MS NC ND NE NJ NM NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV OUS: Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belg
- Date initiated
- 2023-07-12
- Date posted
- 2023-08-31
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS IGA REAGENT (K073489) | Olympus America, Inc. | 2008-02-11 |