Recall
FDAHealthNovember 7, 2025

Beckman Coulter, Inc. — Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Nu

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
November 7, 2025

US Nationwide. Global Distribution.

What's affected?

Product
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 code
P243943

Additional details

UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 38,225 untis.

View original FDA notice →

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