Recall Z-0503-2022— Ortho-Clinical Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2021-11-22. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack. Reason: Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190..
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-11-22
- Firm location
- Rochester, NY, United States
Product description
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Reason for recall
Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
Data sourced from openFDA. This site is unofficial and independent of the FDA.