Recall Z-2482-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho Clinical Diagnostics
VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
| Date | May 20, 2020 |
| Status | Terminated |
| Reason | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances |
| Root cause | Under Investigation by firm |
| Action | Ortho Clinical Diagnostics issued on 20 May 2020, Customer letter (Ref. CL2020-126) sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all VITROS 3600, 5600 and XT7600 . Letter states reason for recall, health risk, and action to take: In the meantime, manually adding the values in both the serum screen AND the plasma screen (even though the plasma screen appears to be updated already) will prevent the issue by correctly marking the edits to both body fluids with M1. To manually enter these values for Plasma in |
| Quantity | 2617 units (U.S.=1272; OUS=1344) |
| Distribution | US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083173 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM Ortho-Clinical Diagnostics, Dec 22, 2008 |