Home / Recalls / Abbott Diagnostics Scarborough, Inc. / Z-1576-2025

Z-1576-2025 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
442,296 eaches

Product Description

Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system 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 435-000; GTIN/DI 10811877010521; Lot 000M906790 Model 435-000; GTIN/DI 10811877010521; Lot 000M907271 Model 435-000; GTIN/DI 10811877010521; Lot 000M923531 Model 435-000; GTIN/DI 10811877010521; Lot 000M923879 Model 435-000; GTIN/DI 10811877010521; Lot 000M924414 Model 435-000; GTIN/DI 10811877010521; Lot 000M924430 Model 435-000; GTIN/DI 10811877010521; Lot 000M926642 Model 435-000; GTIN/DI 10811877010521; Lot 000M926679 Model 435-000; GTIN/DI 10811877010521; Lot 000M927161

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-1575-2025 Class II — Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T (March 4, 2025)