Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Reported: December 28, 2022 Initiated: November 22, 2022 #Z-0739-2023
Product Description
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
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.
Details
- Recalling Firm
- Abbott Molecular, Inc.
- Units Affected
- 3896 kits
- Distribution
- Worldwide
- Location
- Des Plaines, IL
Frequently Asked Questions
What product was recalled? ▼
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096. Recalled by Abbott Molecular, Inc.. Units affected: 3896 kits.
Why was this product recalled? ▼
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2022. Severity: Moderate. Recall number: Z-0739-2023.
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