Z-2487-2021Class II

SARS-CoV-2 Process Control (Swab) -

Name: Z-2487-2021 SARS-CoV-2 Process Control (Swab) -
Creator: Microbiologics Inc
Published: 2021-08-20
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2021-08-20 / Terminated / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid... on 2021-08-20. FDA classified it as Class II and gives the reason as "The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences". 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-2487-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-20
Posted: 2021-09-17
Terminated: 2023-01-12
Recalling firm: Microbiologics, Inc.
Product: SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
Product code: OHQ Multi-Analyte Controls Unassayed
Reason for recall: The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On AUGUST 23, 2021 THE FIRM SENT THE FOLLOWING INSTRUCTIONS TO THEIR CONSIGNEES.: INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage. 3. COMPLETE the response form provided. 4. RETURN the response form to [email protected] 5. KEEP this letter for your records. 6. CONTACT Microbiologics to discuss possible alternatives if replacement is needed Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7073 or [email protected] with questions or concerns. Collect calls may be made.
Quantity in commerce: 127
Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IL, MD, MT, MN, NC, NY, NV, OR, TN, TX,UT, WA and WI. The countries of Austria, Canada, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Japan and United Kingdom.
Product codes and lots: Catalog # HE0063S Lot #'s: HE0063-100-1, HE0063-103-2, HE0063-103-3, HE0063-103-1, HE0063-104-1, HE0063-101-1 and HE0063-100-1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2487-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2487-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-17

Product code OHQ

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)