Tubing — Class II medical device recall Z-0166-2018
Completed recall by Abbott Laboratories, Inc, reported 2017-11-29. The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due t
| Recall number | Z-0166-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Inc, Irving, TX, United States |
| Recall initiated | 2017-09-29 |
| Classified | 2017-11-21 |
| Reported by FDA | 2017-11-29 |
| Countries outside the US | CA, DE, FR |
| Quantity | 44 units |
| Reason classes | packaging |
| Serial numbers | 125589-1-2, 125589-1-4 |
| Model numbers | 7-35009685-01 |
Product
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
Reason for recall
The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
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-0166-2018. 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.