Z-1688-2021Class II

VITROS CoV2 Ag calibrator (Product Code 6199950) -

Name: Z-1688-2021 VITROS CoV2 Ag calibrator (Product Code 6199950) -
Creator: Ortho-Clinical Diagnostics, INc.
Published: 2021-05-03
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2021-05-03 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics, INc. began a recall of VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2... on 2021-05-03. FDA classified it as Class II and gives the reason as "Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1688-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-03
Posted: 2021-05-27
Terminated: 2023-10-24
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On May 4, 2021, Ortho Clinical Diagnostics issued an Urgent Medical Device Correction notice to customers via letter notifying them of calibration failures and the associated condition code for specified calibrator lots. Customers received the following instructions. " Discontinue using VITROS SARS-CoV-2 Antigen Reagent/Calibrator Lot 0064, discard any remaining inventory and switch to an alternate lot. " Ortho will credit and/or replace all remaining inventory of VITROS SARS-CoV-2 Antigen Reagent/Calibrator Lot 0064 as indicated on the Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than MM/DD/YY, even if your facility no longer has the affected product in inventory. " Please forward this notification if the product was distributed outside of your facility.
Quantity in commerce: 74 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, CA, IA, IL, LA, MO, MS, TX, WI, and the countries of Colombia, India, Japan, Italy, Spain, Portugal, France.
Product codes and lots: Unique Identifier: 10758750033591 Lot: 0020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1688-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1688-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-27

Product code QKP

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)