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Brand Name: ID NOW Influenza A/B 2 24T recallZ-1572-2025 · Abbott Diagnostics Scarborough, Inc. · initiated Mar 4, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott Diagnostics Scarborough, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

FDA root cause category: Process change control

What the company is doing

On March 4, 2025 FIELD CORRECTION NOTICE letters were sent to end user customers. Please complete the following actions, as applicable. 1. If you have impacted inventory in stock, then: " Discontinue use of and destroy any remaining inventory of the impacted lots according to your procedures. " Complete and return the Customer Reply Form (Form must be completed, signed and returned to receive a replacement lot). " Please retain this letter for your records. 2. If you have forwarded the product listed above to others in your network, then: - Inform them of this Field Correction Notice, provide to them a copy of this notice and request they take the necessary action. 3. If you do not have impacted inventory in stock, then: - All product lots not identified in Appendix I can continue to be used. If you have questions regarding this information, please contact Sedgwick by phone at 888 671 8858 (available 8am 5pm EST, Monday - Friday). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online (http://www.fda.gov/MedWatch/report.htm), by mail (http://www.fda.gov/MedWatch/getforms.htm), by phone (1-800-332-1088), or by fax (1-800-FDA-0178). If you have experienced any patient or user injury associated with this Field Correction Notice, please immediately report the event to your local area Customer Service. ****Update added 5/8/2025**** On April 29, 2025 FIELD CORRECTION NOTICE letters were sent to customers informing them of additional lots included in this recall.

Recall details

Recall number
Z-1572-2025
Status
Open, Classified
Initiated by the company
Mar 4, 2025
Posted by the FDA
Apr 15, 2025
Recalling firm
Abbott Diagnostics Scarborough, Inc.
Quantity
592320 eaches (535416 US, 56904 OUS)
Product code
OZE
FDA submissions
K232775
Distribution
Worldwide distribution - US Nationwide and the countries of Australia; Austria; Belgium; Bulgaria; Canada; Costa Rica; France; French Polynesia; Germany; Italy; Luxembourg; Malaysia; Netherlands; Paraguay; Poland; Qatar; Saudi Arabia; Slovenia; South Korea; Spain; Switzerland; Taiwan; United Kingdom; Uruguay.

Product description

Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Model 427-000; GTIN/DI 10811877010422; Lot 000M889669 Model 427-000; GTIN/DI 10811877010422; Lot 000M890889 Model 427-000; GTIN/DI 10811877010422; Lot 000M916327 Model 427-000; GTIN/DI 10811877010422; Lot 000M916649 Model 427-000; GTIN/DI 10811877010422; Lot 000M916672 Model 427-000; GTIN/DI 10811877010422; Lot 000M916724 Model 427-000; GTIN/DI 10811877010422; Lot 000M917131 Model 427-000; GTIN/DI 10811877010422; Lot 000M917164 Model 427-000; GTIN/DI 10811877010422; Lot 000M917180 Model 427-000; GTIN/DI 10811877010422; Lot 000M917508 Model 427-000; GTIN/DI 10811877010422; Lot 000M917581 Model 427-000; GTIN/DI 10811877010422; Lot 000M919907 Model 427-000; GTIN/DI 10811877010422; Lot 000M921626 Model 427-000; GTIN/DI 10811877010422; Lot 000M921636 Model 427-000; GTIN/DI 10811877010422; Lot 000M921728 Model 427-000; GTIN/DI 10811877010422; Lot 000M923485 Model 427-000; GTIN/DI 10811877010422; Lot 000M926234 Model 427-000; GTIN/DI 10811877010422; Lot 000M926370 Model 427-000; GTIN/DI 10811877010422; Lot 000M927991 Model 427-000; GTIN/DI 10811877010422; Lot 000M928421 Model 427-000; GTIN/DI 10811877010422; Lot 000M929248 Model 427-000; GTIN/DI 10811877010422; Lot 000M931072 Model 427-000; GTIN/DI 10811877010422; Lot 000M934181 Model 427-000; GTIN/DI 10811877010422; Lot 000M939117 Model 427-000; GTIN/DI 10811877010422; Lot 000M939160 Model 427-000; GTIN/DI 10811877010422; Lot 000M939186 Model 427-000; GTIN/DI 10811877010422; Lot 000M939468 Model 427-000; GTIN/DI 10811877010422; Lot 000M939480 Model 427-000; GTIN/DI 10811877010422; Lot 000M952883

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96519).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page