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Recall Observatory FDA recall evidence

Device product

arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.

Z-0631-2016

December 18, 2015

Class I

Product summary

Firm
Arkray Factory USA, Inc.
Event
Event 72860
Status
Terminated
Classification
Class I
Quantity
11 boxes (25 foil packaged test strips per box)
Official record key
device-enforcement:Z-0631-2016

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 PN5C26

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.