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ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITRO
Recalled June 10, 2015 · FDA recall Z-1707-2015 · ORTHO-CLINICAL DIAGNOSTICS
Hazard
The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels. · FDA Class III
Units
Domestic: 898 units
Sold at
Nationwide Distribution.
Description
The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
Product
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
Manufacturer(s)
ORTHO-CLINICAL DIAGNOSTICS
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →