Recall Z-0937-2017— Sterling Diagnostics, Inc.

Name: FDA recall Z-0937-2017
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: K860142. Product: Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) 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

K860142 — URIC ACID REAGENT SET (COLORIMETRIC)Sterling Diagnostics, Inc.·cleared 1986-02-11

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

Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) 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.