Z-1009-2022Class I

Accula SARS-CoV-2 Test, REF: COV4100

Name: Z-1009-2022 Accula SARS-CoV-2 Test, REF: COV4100
Creator: Mesa Biotech, Inc
Published: 2022-04-06
License: https://open.fda.gov/license/

Mesa Biotech, Inc. / initiated 2022-04-06 / Open, Classified / root cause: manufacturing process

FDA source

MESA BIOTECH, INC began a recall of Accula SARS-CoV-2 Test, REF: COV4100 on 2022-04-06. FDA classified it as Class I and gives the reason as "SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment". 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-1009-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-04-06
Posted: 2022-05-06
Recalling firm: Mesa Biotech, Inc.
Product: Accula SARS-CoV-2 Test, REF: COV4100
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 04/06/22, recall notices were mailed to customers. Customers were informed that the reliability of negative test results is not affected. Customers with affected devices were asked to do the following: 1. Discontinue use of any affected product immediately 2. All affected product must either be returned or discarded. Replacement product will be provided for all returned and discarded product upon receipt of Customer/Distributor Response Sheet. 3. Notify all impacted users in your facility. If you have shipped any of these lots outside of your facility, you must notify those customers or facilities of this voluntary recall. 4. Complete and return the Customer/Distributor Response Sheet, which can be emailed to [email protected] Customers with questions are encouraged to contact the recalling firm at: +1-858-800-4929, or 1-800-955-6288, option 2.
Quantity in commerce: 6162
Distribution: US Nationwide distribution in the states of CA, TX, MA, NY, FL, NC, NJ, GA, CO, HI, PA, WA, NY, VA, MD, KY, WI, IL, PR, ND, MI, TN, AZ, UT.
Product codes and lots: UDI/DI: B540COV41000; P22006-026, P22010-021, P22024-023, P22024-030, P22026-006, P22026-012, P22026-016 , P22010-001, P22010-030, P22024-026, P22024-032, P22026-007, P22026-013, P22026-017 , P22010-017, P22010-032, P22024-027, P22026-002, P22026-008, P22026-014, P22026-019 , P22010-019, P22024-021, P22024-028, P22026-004, P22026-009, P22026-015, P22032-011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1009-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1009-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-06

Product code QJR

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)