Recall Z-0630-2016 ยท CGA Glucose Oxidase, Glucose
Arkray Factory USA, Inc.
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.
| 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 | 88 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
| K041427 | THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS Arkray, Inc., Nov 24, 2004 |