Z-1815-2025Class III

Apo B Reagent, REF: OSR6143

Name: Z-1815-2025 Apo B Reagent, REF: OSR6143
Creator: Beckman Coulter Ireland, Inc.
Published: 2025-04-23
License: https://open.fda.gov/license/

Beckman Coulter Ireland Inc / initiated 2025-04-23 / Open, Classified / root cause: labeling and UDI

FDA source

Beckman Coulter Ireland, Inc. began a recall of Apo B Reagent, REF: OSR6143 on 2025-04-23. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1815-2025
Classification: Class III
Status: Open, Classified
Initiated: 2025-04-23
Posted: 2025-05-23
Recalling firm: Beckman Coulter Ireland Inc
Product: Apo B Reagent, REF: OSR6143
Product code: JHN Turbidimetric Method, Lipoproteins
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot # 2631/UDI: 15099590010409

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1815-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1815-2025	Class III	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-23

Product code JHN

K952466Class IOlympus Apolipoprotein B Immunoturbidimetric ReagentOlympus America, Inc. / cleared 1995-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)