Helix Elite Quality Control Material Recalled for Delayed Detection and QC Failure
Microbiologics Inc is recalling its Helix Elite RSV quality control material (Lot HE0044-131) because the RSV component may produce delayed test results and could fail quality control checks. This Class II recall affects 28 units distributed worldwide.
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: This Class II medical device recall involves a risk-of-harm product, as quality control material failure could prevent detection of equipment malfunctions and lead to false negatives. However, no illnesses or injuries have been reported, and the hazard remains theoretical. Per the severity rubric, this scores as High (3).
Plain-English summary
Microbiologics Inc is recalling the Helix Elite Inactivated Standard quality control material (Catalog Number HE0044N, Lot HE0044-131), which is used by diagnostic laboratories to test and verify their influenza A/B and respiratory syncytial virus (RSV) detection equipment.
The FDA has determined that the RSV component of this quality control material may produce delayed test results (indicated by elevated Ct values) and could potentially fail quality control checks. This means laboratories relying on this material to verify their testing equipment may not properly detect equipment malfunctions.
This recall affects 28 units distributed worldwide, including distribution in the United States (Kentucky, Montana, New Jersey, New York, and Wisconsin) as well as Ireland, Germany, and the United Kingdom.
Healthcare facilities and laboratories that have received this product should stop using Lot HE0044-131 immediately and contact Microbiologics Inc for return and replacement instructions. Any quality control results obtained with this material should be reviewed.
The recalled product
- Product
- Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
- Manufacturer
- Microbiologics Inc
- Hazard
- qc-failure
- delayed-detection
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: 10845357042184
- Lot Number: HE0044-131
Distribution
Distributed nationwide across the United States.
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