FDA Medical Device Recalls (openFDA)
Abbott Diagnostic International, Ltd.: Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
- Recall number
- Z-0023-2007
- Recalling firm
- Abbott Diagnostic International, Ltd.
- Product
- Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
- Status
- Terminated
- Initiated
- 2006-09-07
- Posted
- 2006-10-12
- Terminated
- 2011-09-09
- Reason
- Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
- Root cause
- Other
- Action
- The Device Recall Letter dated September 07, 2006, and Customer Reply Form was sent via Federal Express Priority mail to all customers who received the affected lots.
- Quantity
- 797
- Distribution
- Worldwide, including USA, Puerto Rico, Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, Honduras, Trinidad-Tobago, St. Vincent, Bahamas, Panama, and Cayman Islands.
- Lot, serial or model codes
- Lot# 33266Q100 Expiration Date 11/04/2006
- 510(k) numbers
- ["K935612"]
- PMA numbers
- not on file
- Product code
- JIS
- Firm FEI
- 2623532
- Firm city
- Barceloneta
- Firm state
- PR
- 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