FDA Enforcement
Class I
Terminated
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.
Recall: Z-0631-2016
·
Reported January 27, 2016
Enforcement
- Recall Number
- Z-0631-2016
- 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 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
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 PN5C26
Distribution
Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
Quantity
11 boxes (25 foil packaged test strips per box)