Recall Z-0631-2016 ยท CGA Glucose Oxidase, Glucose
Arkray Factory USA, Inc.
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.
| Date | Jan 15, 2016 (initiated Dec 18, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | The firm sent an Urgent Medical Device Recall letter to customers beginning 12/18/2015. The letter identified affected product, stated the reason for recall and asked for unused product to be returned. For instructions on returning unused product contact Lesty Jaranilla 1-877-538-8872 x3243. |
| Quantity | 11 boxes (25 foil packaged test strips per box) |
| Distribution | Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053401 | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS Arkray, Inc., Mar 24, 2006 |