ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
Reported: November 29, 2017 Initiated: September 29, 2017 #Z-0165-2018
Product Description
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 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.
Details
- Recalling Firm
- Abbott Laboratories, Inc
- Units Affected
- 34 units
- Distribution
- Worldwide distribution to US, Canada, France, and Germany.
- Location
- Irving, TX
Frequently Asked Questions
What product was recalled? ▼
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.. Recalled by Abbott Laboratories, Inc. Units affected: 34 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2017. Severity: Moderate. Recall number: Z-0165-2018.
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