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Recall Observatory FDA recall evidence

Device product

Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.

Z-0827-2015

October 23, 2014

Class II

Product summary

Firm
JAS Diagnostics Inc.
Event
Event 69622
Status
Terminated
Classification
Class II
Quantity
390
Official record key
device-enforcement:Z-0827-2015

Official wording

Reason: Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.

Code information: Lot: N0702011K, Exp. 10/2014; N0702012, Exp. 10/2014; N0702013K, Exp. 10/2014; P010201K, Exp. 04/2015; P010202K, Exp. 04/2015; P010203K, Exp. 04/2015; P010204K, Exp. 04/2015; P010205K, Exp. 04/2015; P010206K, Exp. 04/2015; P0402015K, Exp. 07/2015; P0402016K, Exp. 07/2015; P050207K, Exp. 08/2015; P050208K, Exp. 08/2015; P050209K, Exp. 08/2015; P0502010K, Exp. 08/2015; P0502011K, Exp. 08/2015; P0502012K, Exp. 08/2015; P0502013K, Exp. 08/2015; P0502014K, Exp. 08/2015; and P0802017K, Exp. 11/2015.

Distribution pattern: Worldwide Distribution -- US, including the states of NV, TN, TX, FL, GA, NY, NC, CA, MN, OR and Puerto Rico; and, the countries of France, Jamaica, Haiti, Cayman Islands, Trinidad & Tobago, and Ghana.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.