Z-1058-2022Class II

ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit...

Name: Z-1058-2022 ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit...
Creator: Proterixbio
Published: 2022-04-17
License: https://open.fda.gov/license/

Proterixbio / initiated 2022-04-17 / Terminated

FDA source

PROTERIXBIO began a recall of ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number on 2022-04-17. FDA classified it as Class II and gives the reason as "FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1058-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-17
Posted: 2022-05-11
Terminated: 2024-01-23
Recalling firm: Proterixbio
Product: ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).
FDA root cause: Other
Action: On April 17, 2022, the firm notified affected physicians who had ordered tests and received results since September 2020 via email. Customers were informed that the prior test results may not have been accurate. In addition, customers were instructed to check their stock and destroy any remaining Dried Blood Spot Collection Kits (ProterixBio SARS-CoV-2 RBD Antibody Test sampling kits). Customers should note the number of kits destroyed in their response to the recalling firm. For questions and clarifications regarding this notification please call ProterixBio at 978-901-6649 or email [email protected]. Business hours are 8 am to 4:30 pm, Eastern Time.
Quantity in commerce: 640 kits
Distribution: Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
Product codes and lots: Lots were not coded. All product will be recalled.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1058-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1058-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-18	2022-05-11

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)