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Recall Observatory FDA recall evidence

Device product

arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.

Z-0630-2016

December 18, 2015

Class I

Product summary

Firm
Arkray Factory USA, Inc.
Event
Event 72860
Status
Terminated
Classification
Class I
Quantity
88 boxes (25 foil packaged test strips per box)
Official record key
device-enforcement:Z-0630-2016

Official wording

Reason: One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.

Code information: Lot Number EA4M78

Distribution pattern: Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.