FDA-Device2026-03-25Class IIPROCESSING DEFECT
Abbott ID NOW Influenza A & B 2 test kit recalled for higher invalid result rates
OTHERNationwide distribution
Stop using Abbott ID NOW flu test kit
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
Hazard
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
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-1565-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief