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.
FDA Recall Z-0630-2016 · Posted 2016-01-15
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Recalling FirmArkray Factory USA, Inc.
Recall StatusTerminated
Product CodeCGA
Date Initiated2015-12-18
Date Terminated2017-01-04
Product Quantity88 boxes (25 foil packaged test strips per box)
Reason for Recall
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.
Firm Action
The firm sent an Urgent Medical Device Recall letter to customers beginning 12/18/2015. The letter identified affected product, stated the reason for recall and asked for unused product to be returned. For instructions on returning unused product contact Lesty Jaranilla 1-877-538-8872 x3243.
Root Cause
Component design/selection
Distribution Pattern
Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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