Home / Recalls / Arkray Factory USA, Inc. / Z-0630-2016

Z-0630-2016 Class I Terminated

Recalled by Arkray Factory USA, Inc. — Minneapolis, MN

FDA device recall Z-0630-2016 was initiated by Arkray Factory USA, Inc. on Dec 18, 2015 and is designated Class I. 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… The recall status is terminated (terminated Jan 4, 2017). Affected quantity: 88 boxes (25 foil packaged test strips per box).

Recall details

Product Type: Devices
Report Date: Jan 27, 2016
Initiation Date: Dec 18, 2015
Termination Date: Jan 4, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 88 boxes (25 foil packaged test strips per box)

Product description

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.

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.

Distribution pattern

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

Code information

Lot Number EA4M78

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0630-2016
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.