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.
Get Health recall alerts
Delivered to your inbox. Free. No account required.