Food, drugs, devices › Beckman Coulter Ireland, Inc.
Device recall: Apo B Reagent, REF: OSR6143
FDA enforcement event 96746 is a device recall by Beckman Coulter Ireland, Inc. of O'Callaghan'S Mills, N/A, initiated 23 Apr 2025 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 2% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Beckman Coulter Ireland, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Beckman Coulter Ireland, Inc., O'Callaghan'S Mills, N/A, Ireland.
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…"
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1815-2025 | Apo B Reagent, REF: OSR6143 | 2747 units | Class III | Ongoing | 4 Jun 2025 |
Context
Other enforcement events for Beckman Coulter Ireland, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Dec 2025 | The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol f | Device | Class II | 1 |
| 14 Oct 2025 | BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative de | Device | Class II | 1 |
All 3 events for Beckman Coulter Ireland, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 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…"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.