Z-1163-2025Class II

Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro...

Name: Z-1163-2025 Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro...
Creator: Microbiologics Inc
Published: 2025-01-20
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2025-01-20 / Open, Classified

FDA source

Microbiologics Inc began a recall of Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test on 2025-01-20. FDA classified it as Class II and gives the reason as "Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1163-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-20
Posted: 2025-02-12
Recalling firm: Microbiologics, Inc.
Product: Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Product code: OHQ Multi-Analyte Controls Unassayed
Reason for recall: Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
FDA root cause: Under Investigation by firm
Action: Microbiologics issued and Urgent Medical Device Recall notice to its consignees on 01/20/2025 via email. The notice explained the issue and requested the following actions be taken: INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage 2. DISCARD affected product. 3. COMPLETE the response form provided. 4. RETURN the response form to [email protected] 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. CONTACT Microbiologics if a replacement kit is needed. Please contact our Recall Support team at 320.229.7080 or [email protected] with questions or concerns.
Quantity in commerce: 16 units
Distribution: Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
Product codes and lots: UDI/DI 70845357043077, Lot Number 8234-22

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1163-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1163-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-12
Z-1164-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-12

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)