—#217201

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

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K121214
Affected lot / code info: UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005

Why it was 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.

Root cause (FDA determination)

Process design

Action the firm took

An URGENT MEDICAL DEVICE RECALL notification letter dated 10/29/25 was sent to customers. Check your inventory of Access 2 RVs for the lots listed at the top of this letter. "If you have the lots listed above contact Beckman coulter for replacement RVs. "You may continue to use the lots listed above until you have received a sufficient supply of replacement RVs. Once replacement RVs arrive, then dispose of the lots listed above according to your local regulations. "If you do not have the RV lots listed above, then no further action is needed. Retrospective review of results is not necessary because this issue does not affect individual patient results. Please contact your local Beckman Coulter representative for replacement product requests. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: "Electronically, if you received this communication via email. "Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center: "From our website: http://www.beckmancoulter.com "Contact your local Beckman Coulter Representative for replacement.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: US Nationwide. Global Distribution.

Timeline

Recall initiated: 2025-11-07
Posted by FDA: 2025-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217201. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.