Recall Z-0165-2018
Abbott Laboratories, Inc · initiated September 29, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
Codes / lots: c400073, c400103, c400498, c400600, c400890, c400934, c400935, c401018, c401055, c401056, c401182, c401505, c401520, c401686, c401887, c460196, c460200, c460943, c461550, c803669, c803753, c1600144, c1600249, c1600251, c1600641, c1600720, c1600819, c1600859, c1600976, c1601350, c1601351
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.
FDA-determined 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.
Details
- Recall number
- Z-0165-2018
- Initiated
- September 29, 2017
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 34 units
- Distribution
- Worldwide distribution to US, Canada, France, and Germany.
- Recalling firm
- Abbott Laboratories, Inc, Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0166-2018 Class II | Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due… | 09/29/2017Completed |