FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD/GPRD: Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27; Abbott Laboratories, Abbott Park, IL 60064
- Recall number
- Z-0297-04
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Product
- Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27; Abbott Laboratories, Abbott Park, IL 60064
- Status
- Terminated
- Initiated
- 2003-12-02
- Posted
- 2004-07-20
- Terminated
- 2004-07-20
- 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.
- Quantity
- not on file
- Distribution
- Nationwide and internationally through Abbott affiliates in Colombia, Brazil, Puerto Rico, Japan, Singapore, Hong Kong and Germany.
- Lot, serial or model codes
- all revision numbers, all versions
- 510(k) numbers
- ["K894069"]
- PMA numbers
- not on file
- Product code
- JQW--
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28