Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
FDA device recall Z-2115-2025 · posted 2025-07-11 · Completed
Recall details
- Recalling firm
- Beckman Coulter, Inc.
- Reason for recall
- Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.
- Action taken
- An URGENT MEDICAL DEVICE RECALL notification letter dated 2/19/25 was sent to customers. ACTION: Discontinue using Access Vitamin B12 reagent lot 439850. Discard all remaining reagent packs from this lot following your laboratory procedures. Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to review previous patient results. Contact your local Beckman Coulter representative for replacement product requests. Please share this information with your laboratory staff and 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. 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. If you have any questions regarding this notice, please contact our Customer Support Center: From our website: http://www.beckmancoulter.com You may request replacement product by contacting your local Beckman Coulter Representative for replacement.
- Root cause
- Process control
- Status
- Completed
- Product code
- CDD
- Quantity affected
- 10,000 units
- Distribution
- International distribution to the country of Andorra, Bulgaria, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Maldives, Netherlands, Portugal, Romania, Spain, Switzerland, Turkey, United
- Date initiated
- 2025-02-27
- Date posted
- 2025-07-11
- Location
- Chaska, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS VITAMIN B12 ASSAY (MODIFICATION) (K955436) | Bio-Rad Laboratories, Inc. | 1996-01-24 |