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Beckman Coulter, Inc.: Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Acc

Medical DevicesSource: FDA (device) · Date: 2025-12-17

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Beckman Coulter, Inc.
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
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide. Global Distribution.
Recall initiated
2025-11-07
Code info
UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005
Product quantity
38,225 untis
Voluntary mandated
Voluntary: Firm initiated
City
Chaska
State
MN
Country
United States
Event id
97932
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