HPV Diagnostic Control Panel Recall Due to Quality Control Failures
Microbiologics is recalling a lot of HPV diagnostic control materials due to inadequate quality control during release. The control's HPV 16 L1 concentration is too low, potentially causing test failures and invalid results in clinical laboratories.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II medical device with internal quality control failures. No illnesses or injuries have been reported. The risk is that invalid test results could occur in diagnostic testing, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Microbiologics Inc is recalling Lot 8234-22 of the Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234. This is a laboratory control material used in clinical testing to verify the performance of HPV diagnostic tests.
Internal quality control procedures were not followed correctly during the testing and release of three lots of this product. As a result, products that should have failed quality control inspections and been discarded were released to the market. The HPV 16 L1 target in the affected lots has a concentration that is too low.
The low concentration of the HPV 16 L1 target can cause quality control test failures, failure to detect the target, or invalid test results on some diagnostic instruments and assays. This means that clinical laboratories using this control material may not be able to properly verify whether their HPV diagnostic tests are functioning correctly.
The affected lots were distributed worldwide to customers in the United States, Netherlands, Sweden, United Kingdom, France, Australia, and New Zealand. Laboratory personnel and directors who have this product should stop using the affected lots and contact Microbiologics Inc for replacement materials or further guidance.
The recalled product
- Product
- Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
- Manufacturer
- Microbiologics Inc
- Affected units
- 16
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 (2)
- UDI/DI 70845357043077
- Lot Number 8234-22
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Microbiologics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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