Beckman Coulter Ireland, Inc. 2025-06-04 Health moderate FDA
Health · FDA · Recall #FDA-Z-1815-2025
Apo B Reagent, REF: OSR6143 Recall
Issued June 4, 2025 · Beckman Coulter Ireland, Inc.
In June 2025, Beckman Coulter Ireland, Inc. recalled the Apo B Reagent, REF: OSR6143, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Apo B Reagent, REF: OSR6143 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Beckman Coulter Ireland, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Beckman Coulter Ireland, Inc.
- Category
- Health
- Recall date
- June 4, 2025
- Units affected
- Not reported
- Sold at
- 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 c
- Recall number
- FDA-Z-1815-2025
- Made in
- Ireland
- Issuing agency
- FDA
In context
- Beckman Coulter Ireland, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.