arkray SPOTCHEM II Basic Panel — Class I medical device recall Z-0631-2016
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-0631-2016 |
|---|---|
| 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 | PN5C26 |
| Model numbers | 77484 |
Product
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.
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-0631-2016. 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.