FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
- Recall number
- Z-0166-2018
- Recalling firm
- Abbott Laboratories, Inc
- Product
- Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
- Status
- Completed
- Initiated
- 2017-09-29
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Component design/selection
- Action
- All worldwide ARCHITECT Clinical Chemistry System customers with impacted instruments will receive the Product Correction Letter dated, 9/29/17. A customer reply is requested from all affected consignees.
- Quantity
- 44 units
- Distribution
- Worldwide distribution to US, Canada, France, and Germany.
- Lot, serial or model codes
- Serial numbers - 125589-1-2, 125589-1-4
- 510(k) numbers
- ["K980367"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1628664
- Firm city
- Irving
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28