Z-1664-2023 Class II Ongoing
FDA device recall Z-1664-2023 was initiated by Ortho-Clinical Diagnostics, Inc. on April 14, 2023 and is designated Class II. Reason for recall: Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing The recall status is ongoing. Affected quantity: 132 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2023
- Initiation Date
- April 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 132 units
Product Description
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696
Reason for Recall
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
Distribution Pattern
Nationwide Foreign: Brazil, Chile, Colombia
Code Information
UDI-DI: 10758750006601 Lot Number: 1172 Exp. 20-OCT-2023