Recall Z-0721-03 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
AEROSET System Software version 1.00ER005 Catalog Number 2-89996-01 and 1.00ER005.2 Catalog Number 2-89996-02, distributed by Abbott Laboratories
| Date | Apr 15, 2003 (initiated Dec 12, 2002) |
| Status | Terminated |
| Reason | The autoprint feature allows the switch of patient IDs in remote cases. |
| Root cause | Other |
| Action | The firm sent a Device Correction letter to all consignees on 12/12/2002, requesting that the users make adjustments to their systems, and retain the letter in their user manual. The letter included a customer reply form. The software will be corrected with the release of the next version. |
| Quantity | 640 |
| Distribution | Nationwide and to the following foreign countries: Mexico, Columbia, Dominican Republic, Hong Kong, Guatemala, Argentina, Canada, Australia, Venezuela, Brazil, Germany, New Zeland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.