Z-0772-2024 Class II Ongoing
FDA device recall Z-0772-2024 was initiated by Ortho-Clinical Diagnostics, Inc. on November 27, 2023 and is designated Class II. Reason for recall: Affected lots may experience increased calibration failures or an increase in falsely elevated results. The recall status is ongoing. Affected quantity: 6,920 US; 57 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2024
- Initiation Date
- November 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,920 US; 57 OUS
Product Description
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Reason for Recall
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
Distribution Pattern
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.
Code Information
UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990