Recall Z-1704-2017 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications i
| Date | Apr 3, 2017 (initiated Feb 13, 2017) |
| Status | Terminated |
| Reason | Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match. |
| Root cause | Process control |
| Action | Beckman Coulter sent an Urgent Medical Device Recall letter dated February 13, 2017, was sent to customers to inform them that Beckman Coulter has identified a mismatch in Rack ID Labels (REF MU9074); the Rack ID number displayed and the Rack ID barcode label do not match. Rack ID labels numbered 0161 thru 0180 may be read as 0141 thru 0160 on the AU System. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact their Customer Support Center: http://www.beckmancoulter.com/custo |
| Quantity | 2 sheets (20 labels/sheet) |
| Distribution | US Distribution : MA ., Internationally to Japan |
| FDA record | Open on fda.gov |