—#169917

Product

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.

FDA product code: LEG — Enzyme Immunoassay, Valproic Acid
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K042476
Affected lot / code info: Affected Lots/Expiry: 25-5263 2017-09-09; 25-5503 2018-01-06; 25-5727 2018-04-30; 25-5974 2018-08-14; 25-6067 2018-11-05; 25-6393 2019-04-05 (only non expired lot) Unique Identifier:10758750006748

Why it was recalled

Negative bias results when using VITROS VALP Reagent, GEN 25.

Root cause (FDA determination)

Process control

Action the firm took

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. If you have any GEN 25 (Lot 25-6393) remaining in your inventory, Ortho will provide replacement or credit your account. " Discontinue using Gen 25 (Lot 25-6393), discard any remaining inventory, and switch to GEN 26 or above. " If you do NOT have GEN 26 or above at this time, consider the following alternate options: o Use an alternate valproic acid method until your replacement order arrives. o Consult with your medical director to determine if the bias observed when using GEN 25 is acceptable for continued use, and if so, continue to use until your replacement arrive. In accordance with regulatory requirements, complete and return the Confirmation of Receipt - Response form no later than December 19, 2018 via Fax: 1.888.557.3759 or 1.585.453.4110 or e-Mail Address: RA-OCDUS CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM. " Post this notification by your VITROS System or with your user documentation. " Forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311..

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 1000 Lee Road, Rochester, New York 14606

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-12-11
Terminated: 2020-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169917. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.