Recall Z-1664-2023— Ortho-Clinical Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2023-04-14. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing.
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-04-14
- Firm location
- Raritan, NJ, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.