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U.S. Department of Health and Human Services

Class 2 Device Recall AntiSARSCoV2 Total N Antibody Calibrators

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  Class 2 Device Recall AntiSARSCoV2 Total N Antibody Calibrators see related information
Date Initiated by Firm March 09, 2023
Date Posted April 18, 2023
Recall Status1 Open3, Classified
Recall Number Z-1396-2023
Recall Event ID 92017
Product Classification Reagent, coronavirus serological - Product Code QKO
Product VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody
Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV):
DRVs 6213 through 6218 supporting VITROS Calibrators.
Product Code: 6199976
Code Information UDI: 10758750034581 Lot # /Expiration Date: 0230 22-Feb-2023; 0240 22-Mar-2023; 0250 26-Apr-2023.
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc.
1001 Us Highway 202
Raritan NJ 08869-1424
For Additional Information Contact SAME
908-218-8776
Manufacturer Reason
for Recall		 Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
FDA Determined
Cause 2		 Employee error
Action Ortho Clinical Diagnostics issued Important Product Correction Notification letter on 3/9/23. Letter states reason for recall, health risk and action to take: To calibrate all lots currently within expiring date of Anti-SARS-CoV-2 Total N, load ADD 6219 or higher on your VITROS System. " Complete the enclosed Confirmation of Receipt form no later than March 17, 2023. " Please forward this notification and ADD if the affected product was distributed outside of your facility. " 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. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce 256 units
Distribution US Nationwide distribution in the states of AL, AZ, CA, GA, NY.
Total Product Life Cycle TPLC 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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