Z-1565-2026Class II

Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable...

Name: Z-1565-2026 Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable...
Creator: Abbott Diagnostics Scarborough, Inc.
Published: 2026-02-09
License: https://open.fda.gov/license/

Abbott Diagnostics Scarborough, Inc. / initiated 2026-02-09 / Open, Classified / root cause: labeling and UDI

FDA source

Abbott Diagnostics Scarborough, Inc. began a recall of 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... on 2026-02-09. FDA classified it as Class II and gives the reason as "It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1565-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-09
Posted: 2026-03-13
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
Product code: OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Reason for recall: It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Root cause tag: labeling and UDI
FDA 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 in commerce: 111984 units
Distribution: US Nationwide distribution.
Product codes and lots: List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1565-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1565-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-25	2026-03-13

Product code OZE

K171792Class IIAlere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc. / cleared 2017-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)