ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott… — Class II medical device recall Z-2202-2015
Terminated recall by Abbott Laboratories, reported 2015-07-29, distributed nationwide. The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak
| Recall number | Z-2202-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2015-06-11 |
| Classified | 2015-07-22 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2016-02-09 |
| Distributed | Nationwide (US) |
| Quantity | 5 units |
| Reason classes | packaging |
| Serial numbers | C801911, C802239, C802260, C802312, C802447 |
Product
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.
Reason for recall
The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
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-2202-2015. 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.