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
This recall is currently active, issued April 15, 2025. It was issued by Abbott Diagnostics Scarborough, Inc..
- Recall Initiated
- March 4, 2025
- Posted
- April 15, 2025
- Recall Number
- Z-1575-2025
- Quantity
- 2,776,416 eaches
- Firm Location
- Scarborough, ME
- Official Source
- View on FDA website ↗
Reason for Recall
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Distribution
US Nationwide distribution.
Lot / Code Info
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
Root Cause
Process change control
Action Taken
On March 4, 2025 PRODUCT REMOVAL NOTICE letters were sent to distributors. Necessary Actions to be Taken by Distributor: 1. If you have impacted inventory held in stock, then: "Immediately quarantine impacted product per your local procedure. "Complete and return the Distributor Acknowledgment Form (Form must be completed, signed and returned to receive replacement product). "Contact Customer Service to arrange return of your product by Abbott. 2. If you have forwarded the product listed above to others within your distribution network, then: "Inform them of this Product Removal Notice and provide to them a copy of this notice and request they take the necessary action. 3. If you have forwarded the impacted product to your customers, then: "Provide customer list to Abbott based on the product information in Appendix II as outlined in the distribution agreement within 48 hours of receipt of this Product Removal Notice. "Abbott will notify customers of this Product Removal Notice. 4. If you do not have any inventory of the impacted lot(s), then: "All product lots not identified in Appendix I can continue to be used. If you have questions regarding this information, U.S. Customers please contact Sedgwick at 1 888 671 8858 (available 8am 6pm 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 Removal Notice, please immediately report the event to your local area Customer Service. ****Update 05/08/2025**** On April 29, 2025 Updated PRODUCT REMOVAL NOTICE letters were sent to distributors notifying of additional lots that were included in the recall.