Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagn

FDA device recall Z-1164-2025 · posted 2025-02-12 · Open, Classified

Recall details

Recalling firm

Microbiologics Inc

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.

Action taken

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 recall@microbiologics.com 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 recall@microbiologics.com with questions or concerns.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OHQ

Quantity affected

27 units

Distribution

Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.

Date initiated

2025-01-20

Date posted

2025-02-12

Location

Saint Cloud, MN