Recall Z-1936-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
| Date | Apr 8, 2019 |
| Status | Terminated |
| Reason | Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. |
| Root cause | Device Design |
| Action | On 08 April 2019, a customer letter (Ref. CL2019-090) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and and/or US Postal Service Priority Mail (for PO Boxes only) to either all customers who were shipped affected VITROS 250 or 350 Systems. This communication provided the following required actions: - As per the VITROS CK Slide Instructions for Use, perform Quality Control (QC) testing daily to help ensure the slides are performing within acceptable limits. - If QC results are outside of the established ranges, discard the cartridge and repeat QC testing using a fre |
| Quantity | 3889 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922072 | KODAK EKTACHEM 250 ANALYER Eastman Kodak Company, Jul 10, 1992 |