Abbott Alinity m Resp-4-Plex Amp Kit Recall: False Positive Results Risk
Abbott recalls specific lots of Alinity m Resp-4-Plex Amp Kit due to increased false positive results. Affected units may cause inaccurate test results.
Lower-risk recall
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Contact the company
What happened, in plain English
Abbott is recalling certain lots of Alinity m Resp-4-Plex Amp Kit because they may produce false positive results. This could lead to incorrect test outcomes, especially in medical testing scenarios. Read more at govinfonow.com/recall/59297-abbott-alinity-m-resp-4-plex-amp-kit-recall-false.
Source Summary by GovInfoNow · govinfonow.com/recall/59297-abbott-alinity-m-resp-4-plex-amp-kit-recall-false · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0739-2023
Cite this page
“Abbott Alinity m Resp-4-Plex Amp Kit Recall: False Positive Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59297-abbott-alinity-m-resp-4-plex-amp-kit-recall-false. Based on FDA recall #Z-0739-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0739-2023%22&limit=1).
Why it’s dangerous
The recalled kits may show false positive results due to reactive negative controls. This can cause inaccurate test outcomes, potentially leading to incorrect medical decisions.
Who’s affected
Healthcare professionals using the Alinity m Resp-4-Plex Amp Kit for medical testing are most affected. Patients relying on accurate test results could be impacted by false positives.
How to tell if you have this one
Check for the part number 09N79-096 on the kit. Affected lots include 381465 (exp 8/24/2023), 524433 (exp 1/5/2023), 526710 (exp 1/21/2023), and 527845 (exp 2/8/2023).
- Brand
Abbott- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0739-2023 | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096; Lot Numbers: 381465, exp 8/24/2023; 524433, exp 1/5/2023; 526710, exp 1/21/2023; 527845, exp 2/8/20231499 | 3896 kits |
| Z-0740-2023 | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090; Lot Numbers: 381177, exp 8/24/2023; 525460, exp ; 525766, exp ; 526393, exp ; 526483, exp ; 527142, exp ; 527403, exp ; 527602, exp ; 531612, exp ; | 12116 kits |
What to do — step by step
Check Kit Lot Number
Identify the lot number on the kit to determine if it is affected.
How this recall unfolded
Recall timeline
FDA published this recall 36 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0739-2023 (November 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0739-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.