Diagnostic HPV Verification Panel Recalled Due to Quality Control Failures
Microbiologics Inc is recalling HPV verification test panels (REF 8235) due to quality control failures that allowed defective units to be released. The panels may produce invalid test results or fail to detect HPV.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall involving a risk-of-harm product (diagnostic test panel that may produce invalid results or fail to detect HPV). No hospitalizations, injuries, or illnesses have been reported, keeping the score at 3 rather than 4.
Plain-English summary
Microbiologics Inc is recalling the Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), model REF 8235. This is an in-vitro diagnostic test used to verify HPV testing procedures. The recalled product was distributed worldwide, including to customers in the United States, Netherlands, Sweden, United Kingdom, France, Australia, and New Zealand. Affected lot numbers are 8235-32 and 8235-33.
The recall was initiated because quality control procedures were not followed correctly during product testing and release. Products that should have been discarded due to failing quality standards were released for distribution. One target component (HPV 16 L1) was found to have insufficient concentration.
The low concentration of HPV 16 L1 can cause quality control test failures, lack of detection, or invalid results when the panels are used on certain laboratory instruments and assays. This means the verification panels may not function properly for their intended purpose.
No illnesses or injuries have been reported related to this recall. Customers who have received affected lot numbers should contact Microbiologics Inc for return instructions.
The recalled product
- Product
- Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
- Manufacturer
- Microbiologics Inc
- Hazard
- invalid-test-results
- detection-failure
- quality-control-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 70845357043077
- Lot Numbers: 8235-32
- 8235-33
Distribution
Distributed nationwide across the United States.
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