Recall Z-0936-2017— Sterling Diagnostics, Inc.

Name: FDA recall Z-0936-2017
Creator: U.S. Food and Drug Administration
Published: 2016-07-20

Class III · Terminated

Class III FDA medical device recall by Sterling Diagnostics, Inc., initiated 2016-07-20, terminated 2017-03-22. It names one FDA 510(k) clearance: K860154. Product: 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.. Reason: 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..

Recalling firm: Sterling Diagnostics, Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-07-20
Terminated: 2017-03-22
Firm location: Sterling Heights, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K860154 — BUN (ENZYMATIC BERTHELOT) REAGENT SETSterling Diagnostics, Inc.·cleared 1986-02-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.