Class II U.S. Food and Drug Administration

Abbott Diagnostics Scarborough, Inc. Product Name: ID NOW" Influenza A & B 2 Model/ recall: It was confirmed that the impacted lot has a higher occurrence of invalid

Recall published 7 months ago

It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1565-2026
Published
March 25, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Abbott Diagnostics Scarborough, Inc.
Product type
Medical devices
Units affected
111984 units
Distribution
Nationwide
Made in
United States
Lot / code info
List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
UPC codes
10811877010422

Products covered by this recall

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

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10811877010422

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 000X133126

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2027 02 21

Model or item number

On the rating label, the box or the instruction sheet.

  • 427-000 Software Version

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Abbott Diagnostics Scarborough, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Abbott Diagnostics Scarborough, Inc. — 10 Southgate Rd, Scarborough, ME, 04074-8303

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Abbott Diagnostics Scarborough, Inc. medical devices recalled?

It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10811877010422; lot code 000X133126; best-by date 2027 02 21; model number 427-000 Software Version. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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