Recall Z-1556-2023 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6802413
| Date | May 4, 2023 (initiated Mar 10, 2023) |
| Status | Open, Classified |
| Reason | MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable |
| Root cause | Under Investigation by firm |
| Action | Ortho Clinical issued Important Product Correction letter on 3/10/23 to customers with VITROS XT7600 & 5600 Integrated Systems (CL2023-061) and instructed: Until further notice, Ortho recommends loosening and then retightening all caps for MicroTip reagents or diluents immediately prior to loading them onto the system. Per the V-Docs/Maintenance Troubleshooting Guide instructions, Manual MicroTip Reagent Pack Cap Removal, Chapter 6 Troubleshooting, Remove reagent pack caps manually if they become too tight for the MICROTIP PACK OPENER to uncap. The purpose of executing this procedure is to |
| Quantity | 4895 units |
| Distribution | Nationwide including Puerto Rico and Bermuda Foreign: Australia Belgium Brazil Canada Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081543 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM Ortho-Clinical Diagnostics, Inc., Oct 23, 2008 |