FDAClass IIIJune 10, 2015

VITROS Immunodiagnostic Products Signal Reagent recall

VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products…

Why was VITROS Immunodiagnostic Products Signal Reagent recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 3082, expiry date 7/27/2015

Product
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products…
Recalling firm
ORTHO-CLINICAL DIAGNOSTICS
Quantity
Domestic: 898 units
Distribution
Nationwide Distribution.
Recall date
June 10, 2015
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls