WhichRecall
Class IIReported 2025-12-17

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

Recalled by Beckman Coulter, Inc.

Reason for Recall

It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities

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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.

Recall Number
Z-0889-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-07
Reported
2025-12-17
Distribution
US Nationwide. Global Distribution.
Code Info
UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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