Sterling Diagnostics, Inc. recalls Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination…

Recall date

July 20, 2016

Source

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

Recall number

Z-0933-2017

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

Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.