Z-2771-2020Class II

VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 -

Name: Z-2771-2020 VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 -
Creator: Ortho Clinical Diagnostics
Published: 2020-07-17
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2020-07-17 / Terminated / root cause: manufacturing process

FDA source

Ortho Clinical Diagnostics began a recall of VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic... on 2020-07-17. FDA classified it as Class II and gives the reason as "The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures". 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-2771-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-17
Posted: 2020-08-07
Terminated: 2021-07-16
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On July 17, 2020, the firm issued Urgent Product Correction Notification letters to affected customers. Customers were informed of the potential for erroneous patient sample results, calibration errors, and QC failures when using the impacted product. Customers were asked to do the following; " Visually inspect affected VITROS Anti-SARS-CoV-2 Total (Lots 0010-0037) and IgG (Lots 0010-0013) Reagent Packs to ensure correct reagent bottle configuration " Set aside any pack in which the reagent bottles are positioned incorrectly, so the lot number and pack id can be provided to Ortho. Complete and submit the enclosed Request for Credit Form, including the pack information, to receive credit for an affected pack. " Complete the Confirmation of Receipt form no later than July 28, 2020. " Post this notification by each system that processes an affected lot. " Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 2349 sales units
Distribution: Worldwide distribution - US Nationwide distribution.
Product codes and lots: Lots 0010 - 0013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2771-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2770-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-07
Z-2771-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-07

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