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Open, Classified

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

FDA Recall Z-0739-2023 · Posted 2022-12-20

Recalling FirmAbbott Molecular, Inc.
Recall StatusOpen, Classified
Product CodeQJR
Date Initiated2022-11-22
Product Quantity3896 kits

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.

Firm Action

Abbott Molecular issue an Urgent Field Safety Notice /Field Correction Recall to its consignees on 11/22/2022 by FedEx priority express. The notice explained the issue and requested the following actions: "- Discard inventory of any lots listed in Appendix A below. Contact Abbott Customer Support for credit of any unused kit(s). - If you have forwarded any kits of these lots 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 1-800-55-7042 Option 2."

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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