Recall Z-1913-2016 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,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 6, 2016 |
| Status | Terminated |
| Reason | Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results. |
| Root cause | Software design |
| Action | On 4/6/2016,URGENT PRODUCT CORRECTION NOTIFICATION letters (Ref. CL2016-076, dated 4/06/2016) were sent via FedEx overnight and/or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. Follow enclosed instructions to help decrease the probability of the software anomaly until the software update is installed. Discuss any concerns with previously report results with their Laboratory Medical Director to determine the appropriate course of action. I |
| Quantity | US: 218 units, Foreign: 587 units |
| Distribution | Nationwide, Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. |
| 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 |