Recall Z-1468-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
VITROS® 3600 Immunodiagnostic System Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
| Date | Apr 26, 2012 (initiated Mar 15, 2012) |
| Status | Terminated |
| Reason | Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure. |
| Root cause | Nonconforming Material/Component |
| Action | Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard d |
| Quantity | 173 |
| Distribution | Worldwide Distribution |
| 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 |