FDA-Device2026-03-25Class IIPROCESSING DEFECT
Abbott ID NOW Influenza A & B 2 test kit recalled for higher invalid result rates
What this means
Abbott Diagnostics has recalled certain lots of the ID NOW Influenza A & B 2 test kit because they produce an unusually high number of invalid results compared to what the instructions say to expect. Invalid results mean the test does not give a clear positive or negative answer, requiring a retest.
- Check if you have lot number 000X133126 (expiring 2027-02-21); do not use this lot
- Contact Abbott or your healthcare provider if you used this test kit and got an invalid result
- If you are a healthcare facility or lab, follow your facility's protocol for handling recalled test kits
The agency's original wording
Hazard
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
111984 units
Manufactured in
10 Southgate Rd, N/A, Scarborough, ME, United States
Products
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1565-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.