Severity
Low
LowClass IIIOngoing
FDA Devices recall · Reported June 4, 2025
Apo B Reagent, REF: OSR6143
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 pa…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Beckman Coulter Ireland, Inc. recalled Apo B Reagent, REF: OSR6143 - a low-severity action.
Apo B Reagent, REF: OSR6143 was recalled by Beckman Coulter Ireland, Inc. in June 4, 2025. Reason: The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was include…. Check the official notice for the remedy. Verify recall #Z-1815-2025 with the FDA Devices before acting.
The recall
Beckman Coulter Ireland, Inc. issued this low-severity FDA Devices recall-The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was include….
- Low
- severity level
- 3K units
- affected scope
- Class III
- classification
- June 4, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1815-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1815-2025) was formally reported on June 4, 2025, with the manufacturer initiating the action on April 23, 2025. It is classified under Low severity (Class III), with a current status of Ongoing. Beckman Coulter Ireland, Inc. is listed as the recalling firm, operating out of O'Callaghan'S Mills, N/A. Federal records list the affected scope as 2747 units.
The documented reason for this recall is: 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 tota… Distribution data in the federal record shows the product reached: 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, Cz…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2747 units
Related Recalls
6
3 from same agency
Product description
Apo B Reagent, REF: OSR6143
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-1815-2025 |
| Date reported | June 4, 2025 |
| Date initiated | April 23, 2025 |
| Recalling firm | Beckman Coulter Ireland, Inc. |
| Firm location | O'Callaghan'S Mills, N/A |
| Affected scope | 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, Estoni… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1815-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Apo B Reagent, REF: OSR6143. Recalled by Beckman Coulter Ireland, Inc.. Units affected: 2747 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 4, 2025. Severity: Low. Recall number: Z-1815-2025.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1815-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 4, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.