Arkray Factory USA, Inc. FDA Record
Arkray Factory USA, Inc. has 3 FDA recalls (2 Class I), 3 inspections, 9 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Arkray Factory USA, Inc." is on file.
- Latest recall
- Z-1850-2019 · Class II · May 3, 2019
- Latest inspection
- Aug 16, 2016 · NAI
- Latest 510(k)
- May 19, 2011
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 3 (2 Class I) | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 9 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1850-2019 | Class II | AUTION HYBRID AU-4050 | May 3, 2019 |
| Z-0630-2016 | Class I | arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For… | Dec 18, 2015 |
| Z-0631-2016 | Class I | arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484… | Dec 18, 2015 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 16, 2016 | Doral, FL | Devices | No Action Indicated (NAI) | 1832816 |
| Oct 16, 2012 | Doral, FL | Devices | No Action Indicated (NAI) | 1832816 |
| Jul 22, 2011 | Doral, FL | Devices | Voluntary Action Indicated (VAI) | 1832816 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1832816 | Doral, FL | 3 | Aug 16, 2016 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K110709 | ARK CARE DIABETES MANAGMENT SYSTEM | May 19, 2011 |
| K093819 | ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) | Jun 9, 2010 |
| K092104 | ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM | Nov 24, 2009 |
| K091102 | ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS | Oct 23, 2009 |
| K090653 | POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM | Oct 9, 2009 |
| K090332 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 | Aug 14, 2009 |
| K082417 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 | Oct 21, 2008 |
| K073416 | ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM | Jun 13, 2008 |
| K063771 | GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM | Aug 9, 2007 |
Arkray Factory USA, Inc. and the FDA: common questions
Has Arkray Factory USA, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Arkray Factory USA, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Arkray Factory USA, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Arkray Factory USA, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Arkray Factory USA, Inc.?
The most recent FDA inspection on file ended Aug 16, 2016 at Doral, FL and was classified NAI. FDA has 3 inspections of Arkray Factory USA, Inc. on file.
Has Arkray Factory USA, Inc. had an FDA recall?
Yes. Arkray Factory USA, Inc. has 3 FDA recalls on record, 2 of them Class I, the most serious class. The most recent started May 3, 2019.
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