Beckman Coulter UIBC Reagent Lot 2690 May Cause Erroneous Low Results
Beckman Coulter recalls UIBC reagent lot 2690 for potential erroneous low patient results. Affected units sold with catalog number OSR61205 and UDI 15099590011925.
Lower-risk recall
The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.
Contact the company
What happened, in plain English
Beckman Coulter is recalling a specific lot of UIBC reagent (lot 2690) because it may produce inaccurate low results in patient tests. This could lead to incorrect medical decisions if used without replacement. Read more at govinfonow.com/recall/64460-beckman-coulter-uibc-reagent-lot-2690-may-cause-erroneous-low.
Source Summary by GovInfoNow · govinfonow.com/recall/64460-beckman-coulter-uibc-reagent-lot-2690-may-cause-erroneous-low · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3028-2020
Cite this page
“Beckman Coulter UIBC Reagent Lot 2690 May Cause Erroneous Low Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64460-beckman-coulter-uibc-reagent-lot-2690-may-cause-erroneous-low. Based on FDA recall #Z-3028-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3028-2020%22&limit=1).
Why it’s dangerous
The reagent may produce erroneously high patient results at the low end of the linear range. This could lead to incorrect medical decisions if the results are used for diagnosis or treatment.
Who’s affected
Healthcare professionals using Beckman Coulter AU analyzers with the specific UIBC reagent lot 2690. Patients receiving tests using this reagent may be at risk of incorrect results.
How to tell if you have this one
Check for the catalog number OSR61205 and unique device identifier (UDI) 15099590011925. The affected lot is 2690 with an expiration date of October 1, 2021.
- Brand
Beckman Coulter- Product
Beckman Coulter Inc. recalls UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product- Category
Medical device
What to do — step by step
Check Reagent Lot Number
Look for the lot number 2690 on the reagent packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 3 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of CA, FL and NJ. The countries of Algeria, Egypt, Philippines and Taiwan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, New Jersey.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3028-2020 (August 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3028-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.