Recall Z-1948-2025— Ortho-Clinical Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2025-03-24. It names one FDA 510(k) clearance: K181029. Product: Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes. Component: No, not a component. Reason: It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay..
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-24
- Firm location
- Rochester, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes. Component: No, not a component
Reason for recall
It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.
Data sourced from openFDA. This site is unofficial and independent of the FDA.