VITROS recallZ-1664-2023 · Ortho-Clinical Diagnostics, Inc. · initiated Apr 14, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
FDA root cause category: Under Investigation by firm
What the company is doing
QuidelOrtho (formerly Ortho Clinical Diagnostics) issued Urgent Product Correction Notification Letter on 4/14/23 to Distributors and End/Users. Letter states reason for recall, health risk and action to take: Prior to calibrating VITROS VANC Reagent GEN 50 using VITROS Calibrator Kit 11, Lot 1172, install ADD DRV 6224 or above on your VITROS System(s). " Complete the enclosed Confirmation of Receipt form no later than April 24, 2023. " Forward this notification if VITROS Calibrator Kit 11, Lot 1172 was distributed outside of your facility. " Save this notification with your user documentation or post this notification by each VITROS 5,1 FS/4600/5600/XT 7600 System until ADD DRV 6224 or above has installed. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care" Technical Solutions Center. Contact Information If you have further questions, please contact the Ortho Care Technical Solutions Center at 1-800-421-3311.
Recall details
- Recall number
- Z-1664-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 14, 2023
- Posted by the FDA
- May 30, 2023
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 132 units
- Product code
- DLJ
- Distribution
- Nationwide Foreign: Brazil, Chile, Colombia
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
Code information (models, lots, serial numbers)
UDI-DI: 10758750006601 Lot Number: 1172 Exp. 20-OCT-2023
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 6801696Ortho-Clinical Diagnostics, Inc. · CALIBRATORS, DRUG SPECIFIC1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page