Recall Z-1257-2023 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
| Date | Mar 15, 2023 (initiated Jan 26, 2023) |
| Status | Open, Classified |
| Reason | An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay performance leading to a remote probability of delayed results or reporting erroneous patient results. The subject nut bands were found to not meet the firm's specifications for hardness and had the incorrect material grain direction. Affected instruments were manufactured from December 28, 2017 to October 19, 2022 or had their nut bands replaced during the same period. |
| Root cause | Component change control |
| Action | The recalling firm issued letters dated 1/19/2023 beginning 1/26/2023 via both email and first class mail. The letter explained the issue, which included photographs, impact, and the actions to be taken. The consignee was to inspect the wash arm lead screw nut band for damage following the instructions listed in Appendix B of the letter. This inspection was to be repeated during weekly maintenance until the affected nut band has been replaced. If the nut band appears to be intact and undamaged. the consignee may continue normal operation of the instrument. If Wash Arm Motion Errors are ob |
| Quantity | 4,137 devices (990 U.S. and 3,147 OUS) |
| Distribution | Worldwide and Nationwide Distribution. There was government/military distribution. Foreign distribution was made to Algeria, Andorra, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Bonaire, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croati |
| FDA record | Open on fda.gov |