Recall Z-1736-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.
| Date | Jun 9, 2014 (initiated Apr 10, 2014) |
| Status | Terminated |
| Reason | Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected |
| Root cause | Software design |
| Action | Important Product Correction Letters (CL2014-116, dated 4/10/2014) were sent on 4/10/2014 via FedEx overnight courier or ORTHO PLUS e-Communications to all customers with VITROS 5,1 FS, 5,1 FS Refurbished, 4600,and/or 5600 Systems. They were informed of the issue and advised to: -- Review VITROS ALT, ALTJ, ALKP, ALKPJ, AST, ASTJ, CHE, CHEJ, CK, CKJ, GGT, GGTJ, LDH and LDHJ results generated on VITROS 4600/5600 and 5,1 FS Systems. Do not report any results associated with an MW code. -- Perform repeat testing in singlicate on all samples with results having an MW code. Only results without a |
| Quantity | Domestic - 597 units, Foreign - 1381 units |
| Distribution | Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. |
| FDA record | Open on fda.gov |