ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITR…

Recall date

May 6, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1707-2015

FDA classification

Class III

Brand / firm

ORTHO-CLINICAL DIAGNOSTICS

Sold / distributed

Nationwide Distribution.

Why it was recalled

The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.