FDA-Device2015-12-02Class III
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
Biochemical Diagnostics Inc
Hazard
CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.
Sold states
US Nationwide Distribution
Affected count
Domestic: 4,473 kits
Manufactured in
180 Heartland Blvd, N/A, Edgewood, NY, United States
Products
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0328-2016Don't want to check this manually?
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