FDA recall, , Moderate risk
Abbott Diagnostics Scarborough ID NOW Influenza A & B 2
The ID NOW Influenza A & B 2 has a higher occurrence of invalid rates.
Summary by Recall Canary from the FDA notice
What happened
Abbott Diagnostics Scarborough, Inc., of Scarborough, Maine, recalled the ID NOW Influenza A & B 2, an Influenza A/B virus nucleic acid IVD kit, because it was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. The recall began February 9, 2026, and was added to the FDA's Enforcement Report on March 13, 2026. The product was distributed nationwide in the US.
The recall affects 111,984 units of the product. The FDA classified the recall on March 13, 2026, and it was in the FDA's weekly enforcement report on March 25, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and lot code listed under your product.
ID Now Influenza A & B 2
- Model number
- 427-000
- Lot code
- 000X133126
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Abbott Diagnostics Scarborough, Inc.Scarborough, Maine
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98400
- Recall number
- Z-1565-2026
- Quantity recalled
- 111984 units
All recalls from Abbott Diagnostics Scarborough, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
