FDA-Device2017-01-04Class III

Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

Sterling Diagnostics, Inc.
Hazard

Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.

Sold states
Domestic: MI Foreign: Phillipines VA/DOD: None
Affected count
97
Manufactured in
36645 Metro Ct, N/A, Sterling Heights, MI, United States
Products
Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2017

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