Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality co
Pending LLM rewrite. Source: FDA_DEVICE Z-0889-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- 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
- Manufacturer
- Beckman Coulter, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- UDI-DI: 15099590180249
- Lot Numbers: P243943
- P243971
- P244202 P244344
- P244345
- P250001
- P250002
- P250003
- P250004 and P250005
Distribution
Distributed nationwide across the United States.
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