Devices

Device Recall Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine

Model / Serial
Carton/Bottle Lot Number: S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S9093061A P9093061A S9094081A P9094081A S0097091C P0097091C S0100101B P0100101B S0103042A P0103042A S0103042H P0103042H S0106062A P0106062A S9101022A P9101022A S9101022B P9101022B S9105052A P9105052A
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
Product Description
Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine || Chemistry || Catalog Number: 5019 || When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas.
Manufacturer
Siemens Healthcare Diagnostics Inc
1 Event
- Recall of Device Recall Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine

Manufacturer

Siemens Healthcare Diagnostics Inc

Manufacturer Address
Siemens Healthcare Diagnostics Inc, 2 Edgewater Dr, Norwood MA 02062-4637
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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