Reported Dec 17, 2025 · Ongoing
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and…
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
- Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
- Lot codes and dates
- UDI-DI15099590180249
- Lot Numbers
P243943P243971P244202 P244344P244345P250001P250002P250003P250004 and P250005
- Amount recalled
- 38,225 untis
Where it was sold
- Nationwide
Why it was recalled
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
This product could cause temporary or reversible health problems — stop using it.
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