medical Class II Updated 2019-02-27

Ortho-Clinical Diagnostics recalls VITROS Chemistry Products VALP Reagent Pack. For in vitro di

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
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
View official government recall

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