FDA Medical Device Recalls (openFDA)
Beckman Coulter Ireland, Inc.: Apo B Reagent, REF: OSR6143
- Recall number
- Z-1815-2025
- Recalling firm
- Beckman Coulter Ireland, Inc.
- Product
- Apo B Reagent, REF: OSR6143
- Status
- Open, Classified
- Initiated
- 2025-04-23
- Posted
- 2025-05-23
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Error in labeling
- Action
- 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.
- Quantity
- 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, 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.
- Lot, serial or model codes
- Lot # 2631/UDI: 15099590010409
- 510(k) numbers
- ["K952466"]
- PMA numbers
- not on file
- Product code
- JHN
- Firm FEI
- 1000206808
- Firm city
- Mills
- Firm state
- not on file
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28