FDA Medical devices recall ·
Access 2 Reaction Vessels, individual, disposable… recall
- Recall number
- Z-0889-2026
- Date
- (initiated November 7, 2025)
- Company / brand
- Beckman Coulter, Inc.
1000 Lake Hazeltine Dr, Chaska, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 38,225 untis
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005
Distribution
US Nationwide. Global Distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0889-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.