Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (

FDA device recall Z-1748-2025 · posted 2025-05-12 · Open, Classified

Recall details

Recalling firm

Abbott Molecular, Inc.

Reason for recall

There were reports of an increase in reactive negative controls and false positive results.

Action taken

An Urgent Field Safety Notice/ Field Correction Recall notification letter dated 4/24/25 was sent to customers. Necessary Actions: " Discard inventory of the lot listed in the above table. Contact Abbott Customer Support for replacement of any unused kit(s). " If you have forwarded any kits of this lot to other laboratories, please inform them of this Urgent Field Safety Notice / Field Correction Recall and provide a copy of this letter. " Return the associated Customer Reply form. Please review this information with laboratory personnel and retain this communication for future reference. If you have any questions regarding this communication, please contact your local Abbott representative, or call Abbott Technical Support at 1-800-553-7042 Option 2. We apologize for any inconvenience this may have caused your laboratory.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QJR

Quantity affected

1447 units

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2025-04-28

Date posted

2025-05-12

Location

Des Plaines, IL