Ortho VITROS TT4 Reagent Pack Recalled for Calibration Failures
Ortho Clinical Diagnostics is recalling VITROS TT4 Reagent Packs due to increased unsuccessful calibrations. The recall affects 3,181 units distributed in the US and 23 other countries.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Ortho Clinical Diagnostics is recalling 3,181 units of VITROS Immunodiagnostic Products TT4 Reagent Packs, Product Code 8744468. The recall was initiated because the specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
The affected product is identified by UDI 10758750005147 and Lot Number 2340. The recall covers distribution in the United States and 23 other countries, including Australia, Canada, China, France, Germany, India, Japan, Mexico, and the UK.
This is a Class III recall, which indicates that use of or exposure to the product is not likely to cause adverse health consequences. Users should stop using the affected reagent packs and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
- Manufacturer
- Ortho Clinical Diagnostics
- Hazard
- Affected units
- 3,181
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 10758750005147
- Lot Number: 2340
Distribution
Distributed nationwide across the United States.
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