arkray SPOTCHEM II Glucose Reagent test strips — Class I medical device recall Z-0630-2016
Terminated recall by Arkray Factory USA, Inc., reported 2016-01-27, distributed in FL, IL, KY, MI, NC, NY, OH, TN. One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are be
| Recall number | Z-0630-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arkray Factory USA, Inc., Minneapolis, MN, United States |
| Recall initiated | 2015-12-18 |
| Classified | 2016-01-15 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2017-01-04 |
| Distributed | FL, IL, KY, MI, NC, NY, OH, TN |
| Lot numbers | EA4M78 |
| Model numbers | 77101, 77424 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0630-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.