Recall Z-0889-2026 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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 Number 81901
| Date | Dec 9, 2025 (initiated Nov 7, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process design |
| Action | 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 b |
| Quantity | 38,225 untis |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121214 | ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM Beckman Coulter, Inc., Jun 14, 2013 |