VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD)

FDA device recall Z-1396-2023 · posted 2023-04-18 · Open, Classified

Recall details

Recalling firm

Ortho-Clinical Diagnostics, Inc.

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

Action taken

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.

Root cause

Employee error

Status

Open, Classified

Product code

QKO

Quantity affected

256 units

Distribution

US Nationwide distribution in the states of AL, AZ, CA, GA, NY.

Date initiated

2023-03-09

Date posted

2023-04-18

Location

Raritan, NJ