Abbott STI and HPV Test Kits Recalled for Quality Control Failures
Abbott is recalling Alinity m STI and HPV test kits due to iron leaching that invalidates quality control checks, potentially compromising test result reliability.
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 an FDA Class II recall involving a diagnostic test where quality control mechanisms have failed due to contamination, creating risk of false-negative results. No reported illnesses, injuries, or confirmed diagnostic failures are documented in the source, placing it in the 'risk-of-harm product where injury has not yet been reported' category per the severity rubric.
Plain-English summary
Abbott Molecular is recalling certain Alinity m STI AMP Kit and Alinity m HR HPV AMP Kit products due to quality control failures. The recall affects approximately 15,068 units, with distribution in the United States (including 25 states) and 30 international countries worldwide.
Abbott identified an increase in Error Code 9198 incidents during kit use, indicating that positive control tests are not showing expected reactivity. The root cause is iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System, which causes positive assay controls to become invalidated.
Invalidated controls compromise the ability to verify that test results are accurate and reliable. This Class II recall was issued by the FDA to address the potential for compromised diagnostic accuracy.
The recalled product
- Product
- Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
- Manufacturer
- Abbott Molecular, Inc.
- Hazard
- quality-control-failure
- diagnostic-inaccuracy
- false-negative-risk
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 (6)
- a) REF 09N17-095
- UDI/DI 00884999048591
- b) REF 09N17-090
- UDI/DI 00884999047945
- c) REF 09N17-091
- UDI/DI 00884999049277 All Lots
Distribution
Distributed nationwide across the United States.
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