FDA Device recall Z-1257-2023
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N)
- FDA Device
- Class II
- ongoing
- Published 2023-03-22
On 2023-03-22 the FDA classified a Class II recall of Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N) by Beckman Coulter, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1257-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-26 |
| Published | 2023-03-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
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).
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.
Identifiers
| code_info | UDI number for the Access 2 instruments: 15099590265380. No UDI for Access 2 Section, DxC 60i Packaged, Catalog #A25…UDI number for the Access 2 instruments: 15099590265380. No UDI for Access 2 Section, DxC 60i Packaged, Catalog #A25640. PN 81600N serial numbers: 570512 570513 570514 570515 570516 570517 570518 570519 570520 570521 570522 570523 570524 570525 570526 570527 570528 570529 570530 570531 570532 570533 570534 570535 570536 570537 570538 570539 570540 570541 570542 570543 570544 570545 570546 570547 570548 570549 570550 570551 570552 570553 570554 570557 570559 570560 570562 570563 570564 570565 570566 570567 570568 570569 570570 570571 570572 570573 570574 570575 570576 570577 570578 570579 570580 570581 570582 570583 570584 570585 570586 570587 570588 570590 570591 570592 570593 570594 570598 570599 570600 570601 570602 570603 570604 570605 570606 570607 570608 570609 570610 570611 570612 570613 570614 570615 570616 570617 570618 570619 570620 570621 570622 570623 570624 570625 570626 570627 570628 570629 570630 570631 570632 570633 570634 570635 570636 570637 570638 570639 570640 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1257-2023%22
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