FDA-Device2013-01-16Class II
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Siemens Healthcare Diagnostics Inc
Hazard
When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).
Sold states
Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
Affected count
1130
Manufactured in
2 Edgewater Dr, Norwood, MA, United States
Products
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0640-2013Don't want to check this manually?
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