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Terminated

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 Recall Z-0866-05 · Posted 2005-06-04

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeLEG
Date Initiated2005-04-18
Date Terminated2005-10-13
Product Quantity139 boxes

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042476VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOSOrtho-Clinical Diagnostics, Inc. · 2004-12-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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