Abbott ID NOW influenza test lot shows higher invalid result rates
Abbott is recalling one lot of the ID NOW Influenza A & B 2 test after confirming the lot has a higher occurrence of invalid rates than stated in the Instructions for Use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the test returns invalid results more often than its instructions state, and no injuries are stated in the source.
Plain-English summary
Abbott Diagnostics Scarborough, Inc. is recalling the ID NOW Influenza A & B 2 test, list number 427-000, an influenza A/B virus nucleic acid in vitro diagnostic kit. About 111,984 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Affected product carries UDI-DI 10811877010422, lot number 000X133126, with an expiry of 21 February 2027.
Laboratories can identify affected kits by the list number, UDI and lot number above, and may contact Abbott Diagnostics Scarborough, Inc. for further information.
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
- Manufacturer
- Abbott Diagnostics Scarborough, Inc.
- Category
- Medical Device — Diagnostic test
- Hazard
- invalid-results
- diagnostic-error
- performance-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- List Number: 427-000
- UDI-DI: 10811877010422
- Lot Number: 000X133126
- Expiry: 2027 02 21
Distribution
Distributed nationwide across the United States.
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