FDA Enforcement
Class I
Terminated
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.
Recall: Z-0630-2016
·
Reported January 27, 2016
Enforcement
- Recall Number
- Z-0630-2016
- Event ID
- 72860
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arkray Factory USA, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 27, 2016
- Initiation Date
- December 18, 2015
- Classification Date
- January 15, 2016
- Termination Date
- January 4, 2017
- Address
- 5182 W 76th St, N/A, Minneapolis, MN, 55439-2900, United States
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
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 Info
Lot Number EA4M78
Distribution
Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
Quantity
88 boxes (25 foil packaged test strips per box)