Recall Z-2602-2021 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
| Date | Jul 21, 2021 |
| Status | Terminated |
| Reason | There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped when they reach the end of the outer lane which could result in Delay in providing patient with appropriate medical treatment. New sample needs to be drawn. Substantial discharge of biohazards material - Infection with a human transmissible blood-borne or animal pathogen which could result in Infection with a human transmissible blood-borne pathogen (e.g. infectious HBV, HCV, |
| Root cause | Under Investigation by firm |
| Action | On August 9 & 11, 2021 Beckman Coulter issued a "Urgent Medical Device Recall" Notification via: E-Mail and paper mail. In addition, to informing consignee about the recall device, the firm ask consignees to take the following actions: 1. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. 2. If the DxA System is observed to be routing sample carriers to the outer lane of the Single Drive Transport Segment (B57634), please report your observation to Beckman Coulter. 3. When conducting maintenance or |
| Quantity | 123 systems |
| Distribution | US Nationwide distribution in the states of AL, CA, IL, In, KY, MN, MI, OH, PA, TX, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190298 | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 Beckman Coulter Biomedical GmbH, Oct 4, 2019 |