Z-1367-2022Class II

Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600 Immunodiagnostic...

Name: Z-1367-2022 Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600 Immunodiagnostic...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2022-05-26
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2022-05-26 / Open, Classified / root cause: labeling and UDI

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems... on 2022-05-26. FDA classified it as Class II and gives the reason as "On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1367-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-26
Posted: 2022-07-12
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems. Product Code: 6199960
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: Ortho Clinical Diagnostics issued Important Correction Notification letter (CL2022-135) on May 26, 2022. Letter states reason for recall, health risk and action to take: When using VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack, do not store on-analyzer for longer than 6 weeks. " Until a lot update occurs, OAS for VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack will temporarily require manual monitoring and removal of reagent packs from analyzer no longer than 6 weeks after packs have been opened and loaded onto the analyzer. " Complete the enclosed Confirmation of Receipt form no later than June 9, 2022. " Post this notification by each VITROS ECi/ECiQ/3600/5600/XT 7600 System in your laboratory until further notice. " Please forward this notification if VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack was distributed outside of your facility. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311
Quantity in commerce: 20858
Distribution: Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.
Product codes and lots: UDI-DI :10758750034413. All expired, in-date and future released lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1367-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1367-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-12

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)