FDA Enforcement
Class II
Ongoing
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Recall: Z-0772-2024
·
Reported January 31, 2024
Enforcement
- Recall Number
- Z-0772-2024
- Event ID
- 93632
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ortho-Clinical Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 31, 2024
- Initiation Date
- November 27, 2023
- Classification Date
- January 19, 2024
- Address
- 100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States
Description
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Reason
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
Code Info
UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990
Distribution
Domestic distribution nationwide. OUS distribution to Bermuda, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, France, Belgium, and The Netherlands.
Quantity
6,920 US; 57 OUS