Recall Z-0297-04 ยท JQW Station, Pipetting And Diluting, For Clinical Use
Abbott Laboratories HPD/ADD/GPRD
Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27; Abbott Laboratories, Abbott Park, IL 60064
| Date | Jul 20, 2004 (initiated Dec 2, 2003) |
| Status | Terminated |
| Reason | The Operations Manual has the wrong Farenheit temperature range listed (102-122) instead of (104-122) for the preparation of the Terg-A-Zyme solution used to clean pipettes of the Abbott Commander Flexible Pipetting Center. |
| Root cause | Other |
| Action | Abbott sent 'Important Product Information' letters dated 12/2/03 to the end user accounts, advising them of the error in conversion of the Celsius temperature range to Farenheit in the first step in preparing the Terg-A-Zyme cleaning solution. The letter listed the entire corrected solution preparation procedure and advised the accounts to retain the letter with the Abbott FPC Operations Manual for future reference. |
| Distribution | Nationwide and internationally through Abbott affiliates in Colombia, Brazil, Puerto Rico, Japan, Singapore, Hong Kong and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K894069 | ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER Abbott Laboratories, Aug 21, 1989 |