Recall Z-2414-2024 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
| Date | Jul 23, 2024 (initiated Jun 4, 2024) |
| Status | Open, Classified |
| Reason | The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results. |
| Root cause | Nonconforming Material/Component |
| Action | Letters dated 5/29/2024 were issued via email and postal mail on 6/4/2024. The letter described the issue, the impact, and the action which was that the consignee's Beckman Coulter service representative will contact the consignee to replace parts affected by the issue. The firm will replace all affected USB 2.0 cables. The information in the letter is to be shared with the consignees laboratory staff and if the device has been forwarded to another laboratory, the consignee is requested to send them a copy of the letter. The consignee is requested to respond to the letter within 10 days ei |
| Quantity | 143 devices |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, IN, KS, NH, PA, and TX. The countries of Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer Beckman Coulter, Inc., Nov 10, 2022 |