Z-1396-2023Class II

VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data...

Name: Z-1396-2023 VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2023-03-09
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2023-03-09 / Open, Classified / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213... on 2023-03-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1396-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-09
Posted: 2023-04-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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
Product code: QKO Reagent, Coronavirus Serological
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
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: UDI: 10758750034581 Lot # /Expiration Date: 0230 22-Feb-2023; 0240 22-Mar-2023; 0250 26-Apr-2023.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1396-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1396-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-18

Product code QKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)