FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
This recall has been terminated (originally issued October 12, 2006).
- Recall Initiated
- September 7, 2006
- Posted
- October 12, 2006
- Terminated
- September 9, 2011
- Recall Number
- Z-0024-2007
- Quantity
- 559
- Firm Location
- Barceloneta, PR
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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 / Code Info
Lot # 33362Q100 Expiration Date 11/04/2006
Root Cause
Other
Action Taken
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.