Recall Z-2237-2024 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.
| Date | Jun 28, 2024 (initiated Feb 29, 2024) |
| Status | Open, Classified |
| Reason | The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000 Access Immunoassay Analyzer may generate a System Event log message that indicates PnP errors. Any cancelled tests will have an associated SYS flag. The analyzer may enter the Red-system status because of this issue. The analyzer also may not eject RVs, where unbound conjugate could potentially splash up on the sidewall of the RV, not being properly washed away, resulting in an |
| Root cause | Under Investigation by firm |
| Action | Beckman Coulter issued an Urgent Medical Device Recall notice to its consignees on 05/299/2024 via mail and email. The notice explained the problem with the device, impact to patient and user, and requested the following actions: . Repeat testing should be at the discretion of the laboratory's medical director. . Your Beckman Coulter service representative will contact you to schedule a part replacement for this issue. Contact your Beckman Coulter representative if your laboratory has experienced any PnP errors. For questions regarding this notice, please contact our Customer Support Cent |
| Quantity | 9 instruments |
| Distribution | Worldwide - US Nationwide distribution in the state of Indiana and the countries of Italy, Sweden, Ireland, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.