FDA Device recall Z-0630-2016
arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424
- FDA Device
- Class I
- terminated
- Published 2016-01-27
On 2016-01-27 the FDA classified a Class I recall of arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424 by Arkray Factory Usa, citing 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 gl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0630-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-12-18 |
| Published | 2016-01-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arkray Factory Usa |
| Distribution | FL, IL, KY, MI, NC, NY, OH, TN |
Product
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.
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.
Identifiers
| code_info | Lot Number EA4M78 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0630-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.