Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
This recall has been completed (originally issued September 29, 2017).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- September 29, 2017
- Recall Number
- Z-0166-2018
- Quantity
- 44 units
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution to US, Canada, France, and Germany.
Lot / Code Info
Serial numbers - 125589-1-2, 125589-1-4
Root Cause
Component design/selection
Action Taken
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.
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