arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitativ
FDA device recall Z-0630-2016 · posted 2016-01-15 · Terminated
Recall details
- Recalling firm
- Arkray Factory USA, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 88 boxes (25 foil packaged test strips per box)
- Distribution
- Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
- Date initiated
- 2015-12-18
- Date posted
- 2016-01-15
- Date terminated
- 2017-01-04
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS (K041427) | Arkray, Inc. | 2004-11-24 |