ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for… — Class II medical device recall Z-0163-2016
Terminated recall by Abbott Laboratories, Inc, reported 2015-11-04, distributed nationwide. Incorrect tubing.
| Recall number | Z-0163-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Inc, Irving, TX, United States |
| Recall initiated | 2015-09-09 |
| Classified | 2015-10-26 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2016-11-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, DE, FR, GR, IN, IT, JP, NL |
| Quantity | 65 units |
Product
ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
Reason for recall
Incorrect tubing.
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-0163-2016. 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.