The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0234-2025·Announced 2024-11-06

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.

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 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.
Category
Medical Device — Diagnostic Test Kit
Hazard
Affected units
15,068

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.

The notice also names 25 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Abbott Molecular, 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.

See all 2 products in this recall →

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