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Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090

FDA Recall #Z-0740-2023 — Class II — November 22, 2022

Recall #Z-0740-2023 Date: November 22, 2022 Classification: Class II Status: Ongoing

Product Description

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090

Reason for Recall

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

Recalling Firm

Abbott Molecular, Inc. — Des Plaines, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

12116 kits

Distribution

Worldwide

Code Information

Lot Numbers: 381177, exp 8/24/2023; 525460, exp ; 525766, exp ; 526393, exp ; 526483, exp ; 527142, exp ; 527403, exp ; 527602, exp ; 531612, exp ;

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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