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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products Calibrator Kit 11

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 Class 2 Device Recall VITROS Chemistry Products Calibrator Kit 11see related information
Date Initiated by FirmApril 14, 2023
Date PostedMay 30, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1664-2023
Recall Event ID 92245
Product Classification Calibrators, drug specific - Product Code DLJ
ProductVITROS 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 UDI-DI: 10758750006601 Lot Number: 1172 Exp. 20-OCT-2023
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc.
1001 Us Highway 202
Raritan NJ 08869-1424
For Additional Information ContactSAME
908-218-8776
Manufacturer Reason
for Recall		Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
FDA Determined
Cause 2		Under Investigation by firm
ActionQuidelOrtho (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.
Quantity in Commerce132 units
DistributionNationwide Foreign: Brazil, Chile, Colombia
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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