Recall Z-2068-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
| Date | Jul 23, 2012 (initiated May 21, 2012) |
| Status | Terminated |
| Reason | software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment. |
| Root cause | Software design |
| Action | Ortho Clinical Diagnostics notified its foreign direct account consignees via email on May 21, 2012 and their direct account US consignees were sent an Urgent Distributor Safety Notice on May 22, 2012 via US Postal Service Priority Letter. The recall letter notified the consignees of the situation and that Ortho will replace their remaining inventory of non-expired GENs 14 or 15 for VITROS VALP Reagent only. Until then the consignees can continue using the VITROS VALP Reagent, GENs 14 or 15 until the replacement arrives. And to note that VITROS VANC Reagent, GENs 19 &20 are now expired. -- |
| Quantity | 1387 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal. |
| 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 |