Recall Z-0263-04 ยท JQP Calculator/Data Processing Module, For Clinical Use
Abbott Laboratories, Inc
The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
| Date | Dec 24, 2003 (initiated Nov 17, 2003) |
| Status | Terminated |
| Reason | 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) |
| Root cause | Other |
| Action | 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. |
| Quantity | 148 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |