Sterling Diagnostics, Inc. recalls Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes…

Recall date

July 20, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0936-2017

FDA classification

Class III

Brand / firm

Sterling Diagnostics, Inc.

Sold / distributed

Domestic: MI Foreign: Phillipines VA/DOD: None

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.