Abbott Alinity m HPV test kit control failures from iron contamination
Abbott is recalling 13,318 units of its Alinity m HPV AMP Kit due to iron leaching into the lysis solution, causing positive controls to fail and potentially producing false negative test results.
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 is a Class II device with a manufacturing defect that creates a significant risk of harm: false negative HPV test results could delay cervical cancer screening follow-up. Although no illnesses or injuries are reported, the hazard is real and not merely theoretical given the documented iron contamination and control failures.
Plain-English summary
Abbott Molecular is recalling 13,318 units of its Alinity m HPV AMP Kit (used with the Alinity m System) due to increased incidences of Error Code 9198, which indicates that positive controls are non-reactive.
The root cause is iron leaching from the lysis transfer pump into the Alinity m Lysis Solution. This iron contamination invalidates the positive assay controls that are designed to verify test runs are functioning correctly.
When positive controls fail, the reliability of test results is compromised. Patients may receive false negative results—being incorrectly reported as HPV-negative when they may actually be positive. This poses a risk to cervical cancer screening programs that depend on accurate HPV detection.
The affected product codes are REF 09N15-095, REF 09N15-090, and REF 09N15-091 (all lots). The recall impacts units distributed nationwide across the US and internationally to 26 countries.
The recalled product
- Product
- Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
- Manufacturer
- Abbott Molecular, Inc.
- Hazard
- assay-control-failure
- false-negative-risk
- iron-contamination
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 (7)
- a) REF 09N15-095
- UDI/DI 00884999048614
- b) REF 09N15-090
- UDI/DI 00884999047921
- c) REF 09N15-091
- UDI/DI 00884999049529
- All Lots
Distribution
Distributed nationwide across the United States.
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