Recall Z-0848-2019 ยท LEG Enzyme Immunoassay, Valproic Acid
Ortho-Clinical Diagnostics
VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.
| Date | Dec 11, 2018 |
| Status | Terminated |
| Reason | Negative bias results when using VITROS VALP Reagent, GEN 25. |
| Root cause | Process control |
| Action | The firm, Ortho Clinical Diagnostics, issued on 11 December 2018, a "URGENT PRODUCT CORRECTION NOTIFICATION" customer letter (Ref. CL2018-267) sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who were shipped VITROS Chemistry Products VALP GEN 25. Foreign affiliates were informed by email on 11 December 2018 of the issue and instructed to notify affected consignees of the issue and appropriate actions to take. The customers were notified of the issue and instructed to cease use of VALP GEN 25. I |
| Quantity | 9014 Total (U.S. = 6798; OUS: U.S. = 2216) |
| Distribution | Worldwide distribution- US (Nationwide) and countries of: Australia, Belgium, Bermuda, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042476 | VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS Ortho-Clinical Diagnostics, Inc., Dec 1, 2004 |