The ARCHITECT i2000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
FDA device recall Z-0262-04 · posted 2003-12-24 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- 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)
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 223
- 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.
- Date initiated
- 2003-11-17
- Date posted
- 2003-12-24
- Date terminated
- 2004-10-28
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT ARCHITECT TESTOSTERONE (K983212) | Abbott Laboratories | 1998-11-18 |