FDA (Devices) recall action 75591
The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Sterling Diagnostics is recalling HDL Cholesterol diagnostic kits because previously extended expiration dates were rescinded.
Sterling Diagnostics is recalling 165 Colorimetric SGOT diagnostic kits because previously extended expiration dates were rescinded.
Sterling Diagnostics is recalling 173 Enzymatic Uric Acid diagnostic kits because previously extended expiration dates were rescinded.
Sterling Diagnostics is recalling 97 units of Enzymatic Cholesterol diagnostic kits due to a revision of previously extended expiration dates.
Sterling Diagnostics is recalling Serum Iron/IBC diagnostic kits because previously extended expiration dates were rescinded.
Sterling Diagnostics is recalling 182 units of Creatinine/Endpoint diagnostic kits because previously extended expiration dates were rescinded.
Sterling Diagnostics is recalling 40 units of Enzymatic Glucose diagnostic kits due to a revision of previously extended expiration dates.
Sterling Diagnostics is recalling SGPT Colorimetric kits because previously extended expiration dates were rescinded.
Sterling Diagnostics is recalling 131 Urea Nitrogen diagnostic kits because previously extended expiration dates were rescinded. The kits were distributed in Michigan and the Philippines.