VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Check against the official notice below — it lists the full affected range.
Ortho Clinical Diagnostics is recalling 3,181 units of VITROS Immunodiagnostic Products TT4 Reagent Pack (Product Code 8744468, Lot Number 2340) distributed nationwide in the US and internationally across 24 countries including Canada, the UK, Germany, France, Japan, Australia, and Brazil. The reagent packs are subject to recall due to an increase in the frequency of unsuccessful calibrations.
The source does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
Reason for recall: The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. Distribution: US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK. Quantity: 3181 Lot/code info: UDI: 10758750005147; Lot Number: 2340
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.