FDA Device recall Z-0165-2018
ARCHITECT c4000 part number 02P24
- FDA Device
- Class II
- completed
- Published 2017-11-29
On 2017-11-29 the FDA classified a Class II recall of ARCHITECT c4000 part number 02P24 by Abbott Laboratories, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0165-2018 |
| Classification | Class II |
| Status | completed |
| Initiated | 2017-09-29 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Abbott Laboratories |
| Distribution | n/a |
Product
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
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.
Identifiers
| code_info | c400073, c400103, c400498, c400600, c400890, c400934, c400935, c401018, c401055, c401056, c401182, c401505, c401520,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0165-2018%22
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