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Recall Observatory FDA recall evidence

Device 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.

Z-0937-2017

July 20, 2016

Class III

Product summary

Firm
Sterling Diagnostics, Inc.
Event
Event 75591
Status
Terminated
Classification
Class III
Quantity
173
Official record key
device-enforcement:Z-0937-2017

Official wording

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.

Code information: Urea Nitrogen/Color BUN, CAT No. 2305-O , Lot No. 30551, Expriry: 7/18, Manufactured: 07/21/15

Distribution pattern: Domestic: MI Foreign: Phillipines VA/DOD: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.