Microbiologics Inc: Medical Device Recall in 2025 - (Recall #: Z-1164-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 20, 2025

Date Posted: February 19, 2025

Recall Number: Z-1164-2025

Event ID: 96166

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.

Status: Ongoing

Product Quantity: 27 units

Code Information:

UDI/DI 70845357043077, Lot Numbers: 8235-32, 8235-33

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated