The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
This recall has been terminated (originally issued December 24, 2003).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- November 17, 2003
- Posted
- December 24, 2003
- Terminated
- October 28, 2004
- Recall Number
- Z-0263-04
- Quantity
- 148
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234)
Distribution
Mexico, Puerto Rico, Japan, Taiwan, Australia, Colombia, Cananda, Hong Kong, New Zealand, Netherlands, Singapore, Germany, Grand Cayman, Korea, Chile, Thailand, TX, PA, SC, CA, IN.
Lot / Code Info
List Number 1G06-01, all serial numbers
Root Cause
Other
Action Taken
The firm plans to distribute a Product Information Letter and an updated ARCHITECT i System Operations Manufal Addendum to all US ARCHITECT customers. An electronic version of these documents was sent to all Abbott affilities worldwide for distribution to their ARCHITECT customers.