Beckman Coulter Access Unconjugated Estriol System: False High uE3 Results
Beckman Coulter recalls Access Unconjugated Estriol systems with REF 33570 due to false elevated uE3 results. Affected units have specific serial numbers. No action needed as the hazard is not dangerous in normal use.
Lower-risk recall
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
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What happened, in plain English
Beckman Coulter is recalling Access Unconjugated Estriol systems with serial numbers 921133, 921348, and 921742. The recall is due to a chemical interference that can cause false high results for unconjugated estriol tests. This does not pose a safety risk to users. Read more at govinfonow.com/recall/64426-beckman-coulter-access-unconjugated-estriol-system-false-high-ue3-results.
Source Summary by GovInfoNow · govinfonow.com/recall/64426-beckman-coulter-access-unconjugated-estriol-system-false-high-ue3-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3006-2020
Cite this page
“Beckman Coulter Access Unconjugated Estriol System: False High uE3 Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64426-beckman-coulter-access-unconjugated-estriol-system-false-high-ue3-results. Based on FDA recall #Z-3006-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3006-2020%22&limit=1).
Why it’s dangerous
The system can produce false high results for unconjugated estriol (uE3) due to alkaline phosphatase interference. This may lead to incorrect pregnancy test interpretations but does not cause physical harm.
Who’s affected
Pregnant women and healthcare providers using Beckman Coulter Access Unconjugated Estriol systems with serial numbers 921133, 921348, or 921742 are most at risk of inaccurate test results.
How to tell if you have this one
Check the serial numbers on the system: 921133, 921348, or 921742. The product is labeled as 'Beckman Coulter Access Unconjugated Estriol, REF 33570'.
- Brand
Beckman Coul: 1-2 words max- Product
Beckman Coulter Inc. recalls BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570- Category
Medical device
What to do — step by step
Check Serial Numbers
Look for serial numbers 921133, 921348, or 921742 on the system.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 32 states.
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, WA, WI and Puerto Rico. The countries…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 3.7 years 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.
Questions people ask
Do I need to stop using this product?
No action is needed as the hazard does not cause injury or require immediate discontinuation.
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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-3006-2020 (August 26, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3006-2020 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.