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Abbott Diagnostics Scarborough, Inc. FDA Recalls

7 recalls on file across devices, 0 of them Class I and 7 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product DescriClass IIFeb 9, 2026It was confirmed that the impacted lot has a higher occurren
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product DescClass IIMar 4, 2025The impacted lots have a higher occurrence of invalid rates
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software VersionClass IIMar 4, 2025the impacted lots have a higher occurrence of invalid rates
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product DescClass IIMar 4, 2025the impacted lots have a higher occurrence of invalid rates
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software VClass IIMar 4, 2025the impacted lots have a higher occurrence of invalid rates
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software VersionClass IIMar 4, 2025The impacted lots have a higher occurrence of invalid rates
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software VClass IIMar 4, 2025The impacted lots have a higher occurrence of invalid rates

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