Abbott ID NOW Influenza A & B 2 test kit recalled for higher invalid result rates
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.
From the FDA notice · Read the official notice ↗ · All Abbott recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 111984 units
- Illnesses reported
- None reported
- Manufactured in
- 10 Southgate Rd, N/A, Scarborough, ME, United States
- Classification
- Class II
- Recall number
- Z-1565-2026
In the FDA's words
- Description
- 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 It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21; Distribution: US Nationwide distribution. Affected quantity: 111984 units
- Hazard
- It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.