FDA Enforcement
Class II
Ongoing
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
Recall: Z-0889-2026
·
Reported December 17, 2025
Enforcement
- Recall Number
- Z-0889-2026
- Event ID
- 97932
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Beckman Coulter, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 17, 2025
- Initiation Date
- November 7, 2025
- Classification Date
- December 9, 2025
- Address
- 1000 Lake Hazeltine Dr, N/A, Chaska, MN, 55318-1037, United States
Description
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
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.
Code Info
UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005
Distribution
US Nationwide. Global Distribution.
Quantity
38,225 untis