Reported May 6, 2020 · Terminated
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
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 · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
- Lot codes and dates
- UDI10758750005147
- Lot Number2340
- Amount recalled
- 3181
Where it was sold
- Nationwide
Why it was recalled
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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