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ID NOW COVID-19 2.0 Control Swab Kit

Alere Scarborough, Inc. · Model 192-080 · UDI-DI 00811877011361

QWR Prescription
1
510(k) clearances
161
Adverse events
2
Recalls
4
Facilities

Description

Control Swabs intended for use only with the ID NOW™ COVID-19 2.0 product. Refer to the ID NOW COVID-19 2.0 Product Insert for instructions for use.

Recalls

DateFirmReason
2025-03-04Abbott Diagnostics Scarborough, Inc.the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
2025-03-04Abbott Diagnostics Scarborough, Inc.The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.