—#38786

Product

VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626.

FDA product code: LEG — Enzyme Immunoassay, Valproic Acid
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K042476
Affected lot / code info: 01-5871, Exp. 31Jan06

Why it was recalled

Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.

Root cause (FDA determination)

Other

Action the firm took

Letters dated 4/18/2005 with instructions to process a mid-level QC fluid every eight hours when processing patient samples for valproic acid. Replacement product to be shipped as soon as available.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: 37 U.S. consignees nationwide. Ortho-Clinical foreign affiliates in England, France and Spain.

Timeline

Recall initiated: 2005-04-18
Posted by FDA: 2005-06-04
Terminated: 2005-10-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38786. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.