Home / Recalls / Abbott Diagnostics Scarborough, Inc. / Z-1575-2025

Z-1575-2025 Class II Ongoing

Recalled by Abbott Diagnostics Scarborough, Inc. — Scarborough, ME

Recall Details

Product Type
Devices
Report Date
April 23, 2025
Initiation Date
March 4, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,776,416 eaches

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

Reason for Recall

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

Distribution Pattern

US Nationwide distribution.

Code Information

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

Other recalls by Abbott Diagnostics Scarborough, Inc.

  • Z-1572-2025 Class II — Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T (March 4, 2025)
  • Z-1571-2025 Class II — Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/ (March 4, 2025)
  • Z-1573-2025 Class II — Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 43 (March 4, 2025)
  • Z-1574-2025 Class II — Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/ (March 4, 2025)
  • Z-1576-2025 Class II — Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 43 (March 4, 2025)