Arkray Factory USA, Inc. Recall: arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, P
Arkray Factory USA, Inc. Recall: arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, P is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Arkray Factory USA, Inc.; Product: arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Bl
| Recalling firm | Arkray Factory USA, Inc. |
|---|---|
| Product | 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. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN. |
| Recall initiated | 20151218 |
| Recall number | Z-0631-2016 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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