Reported Jun 10, 2015 · Terminated
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360…
Ortho-Clinical Diagnostics
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ORTHO-CLINICAL DIAGNOSTICS · FELINDRE MEADOWS · Bridgend, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
Lot 3082expiry date 7/27/2015
- Amount recalled
- Domestic: 898 units
Where it was sold
- Nationwide
Why it was recalled
The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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