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CLASS II · ModerateFDA

Beckman Coulter, Inc. recalls Access 2 Reaction Vessels

📅 Nov 7, 2025 · 📍 Nationwide
Recalling company
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
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 – may cause temporary or medically reversible health consequences
Recall date
Nov 7, 2025
Reported
Dec 17, 2025
Distribution
US Nationwide. Global Distribution.
Status
Ongoing
Quantity
38,225 untis
Lot / codes
UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005
Company location
Chaska, MN
Recall type
Voluntary: Firm initiated
Recall number
Z-0889-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0889-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.