Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Abbott Alinity m Resp-4-Plex Amp Kit Recalled by Abbott Molecular, Inc. Due to Reports of an increase in reactive negative controls...

Date: November 22, 2022
Company: Abbott Molecular, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Molecular, Inc. directly.

Affected Products

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

Quantity: 3896 kits

Why Was This Recalled?

Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.

Where Was This Sold?

Worldwide

About Abbott Molecular, Inc.

Abbott Molecular, Inc. has 30 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report