Apo B Reagent, REF: OSR6143 recallZ-1815-2025 · Beckman Coulter Ireland, Inc. · initiated Apr 23, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter Ireland, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-1815-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 23, 2025
- Posted by the FDA
- May 23, 2025
- Recalling firm
- Beckman Coulter Ireland, Inc.
- Quantity
- 2747 units
- Product code
- JHN
- FDA submissions
- K952466
- 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, Canada, China, Czechia, Egypt, Estonia, France, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Netherlands, New Zealand, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland, United States of America, Viet Nam.
Product description
Apo B Reagent, REF: OSR6143
Code information (models, lots, serial numbers)
Lot # 2631/UDI: 15099590010409
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AU OSR6143Beckman Coulter, Inc. · Turbidimetric Method, Lipoproteins1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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