FDA Medical Device Recalls (openFDA)
Abbott Diagnostics Scarborough, Inc.: 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
- Recall number
- Z-1565-2026
- Recalling firm
- Abbott Diagnostics Scarborough, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2026-02-09
- Posted
- 2026-03-13
- Terminated
- not on file
- Reason
- It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Root cause
- Under Investigation by firm
- Action
- On or about February 9, 2026 Product Removal Notice letters were sent to customers and distributors. Actions to be taken: " Quarantine and discontinue use of any remaining inventory of the impacted lot. " Count how many unused kit boxes (24 tests / 1 kit box) of remaining impacted inventory require replacement. " Complete and return the Customer Acknowledgment Form (Form must be fully completed, signed and returned to receive replacement product). " Complete the Customer Request for Replacement Product Form. " Customer Service will arrange replacement product and return of your product. " Retain this letter for your records. forward this notice to those you have further distributed or transferred product to.
- Quantity
- 111984 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
- 510(k) numbers
- ["K171792"]
- PMA numbers
- not on file
- Product code
- OZE
- Firm FEI
- 1221359
- Firm city
- Scarborough
- Firm state
- ME
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28