Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software... recall (Abbott Diagnostics Scarborough, Inc.)
Medical deviceClass IIOngoing
Summary: Abbott Diagnostics Scarborough, Inc. is recalling 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. Reason: It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
What is being recalled
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
Why
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1565-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 9, 2026 |
| Reported | March 25, 2026 |
| Company | Abbott Diagnostics Scarborough, Inc. |
| Company location | Scarborough, ME, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 111984 units |
More recalls from Abbott Diagnostics Scarborough, Inc. · all medical device recalls · recalls from February 2026