AMS BUN UREA NITROGEN For the In vitro quantitative determination of… — Class II medical device recall Z-1267-2014
Terminated recall by AMS Diagnostics, LLC, reported 2014-04-02, distributed nationwide. Marketing the devices outside 510(k) requirements
| Recall number | Z-1267-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMS Diagnostics, LLC, Weston, FL, United States |
| Recall initiated | 2014-02-11 |
| Classified | 2014-03-21 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2016-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 167 kits |
| Lot numbers | 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 131083, 131084, 131085, 131086, 131087, 131088, 131089, 141081 |
| Model numbers | 40072, 40146, 81046 |
Product
AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
Reason for recall
Marketing the devices outside 510(k) requirements
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-1267-2014. 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.