Apo B Reagent, REF: OSR6143
FDA device recall Z-1815-2025 · posted 2025-05-23 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter Ireland, Inc.
- Reason for recall
- The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
- Action taken
- On April 23, 2025, Beckman Coulter issued a "Urgent Medical Device Recall" Notification to affected consignees via mail and E-Mail. Beckman Coulter asked consignees to take the following actions: 1. If your laboratory is reporting Apo B results generated using the combination of reagent OSR6143, Lot 2631 and calibrator ODR3022, Lot 3000 in mg/dL units, a retrospective review of patient results greater than 77 mg/dL and less than 176 mg/dL is recommended. 2. Discard the value assignment sheet located within each kit of Apo B OSR6143 Lot 2631. 3 Download the updated VAS kit insert from the Beckman Coulter website by searching LOSR6143_2631_ML.02. Beckman Coulter Diagnostics | Beckman Coulter. 4. Ensure that the level 4 calibrator ODR3022, Lot 3000 target value used for calibration of Apo B OSR6143 Lot 2631 is 116 mg/dL and aligns with the corrected VAS. 5. 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(s) listed above to another laboratory, please provide them a copy of this letter.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- JHN
- Quantity affected
- 2747 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MD, MI, NJ, NY, OH, OK, OR, PA, TX, VA, WA, WV and the countries of Argentina, Australia, Belarus, Belgium, Bulgaria
- Date initiated
- 2025-04-23
- Date posted
- 2025-05-23
- Location
- Mills, Ireland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT (K952466) | Olympus America, Inc. | 1995-06-05 |