Z-0631-2016 Class I Terminated
FDA device recall Z-0631-2016 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: 11 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
- 11 boxes (25 foil packaged test strips per box)
Product description
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.
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 PN5C26
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0631-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026