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Clinitek Novus® Cal 1-4 kit

Siemens Healthcare Diagnostics Inc. · Model 10697753 · UDI-DI 00630414590950

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1
510(k) clearances
7
Adverse events
2
Recalls
77
Facilities

Description

Clinitek Novus® calibration kit for use with CLINITEK Novus® automated urine chemistry system

Recalls

DateFirmReason
2023-05-22Universal Meditech Inc.Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2023-05-22Universal Meditech Inc.Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri

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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.