Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02
This recall has been terminated (originally issued February 14, 2006).
- Recall Initiated
- December 23, 2005
- Posted
- February 14, 2006
- Terminated
- April 24, 2012
- Recall Number
- Z-0516-06
- Quantity
- 13961
- Firm Location
- South Pasadena, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The two Multiconstituent Calibrator (MCC) lot numbers 19906M200 and 20879M100 failed to meet product performance expectations throughout the labeled expiration period, as a result of the shortened expiration dating, two lots are now expired. The expiration date for Lot number 26674M100 will be revised from 2006-07-31 to 2006-01-31.
Distribution
Nationwide plus worldwide in Mexico,Venezuela, Chile, Brazil, San Salvador, Singapore, Korea, Trinidad, Grand Cayman, Guatemala, Columbia, Uruguay, Puerto Rico, Canada, Hong Kong, Australia, Bermuda, Jamaica, Costa Rica, Ecuador, Argentina, Dominican ReD., Germanv, Thailand, New Zealand, Bahamas, Panama, & Paraguay.
Lot / Code Info
Lot number(s): 19906M200 (expiration date 02/28/2006), 20879MIOO (expiration date 02/28/2006), & 26674MIOO (expiration date 07/31/2006)
Root Cause
Other
Action Taken
A Device Correction letter identifying the changes being made to the expiration dating for lot numbers 19906M200, 20879MI00 and 26674M1O0 along with a Customer Reply form will be distributed via FedEx to all AEROSET and ARCHITECT c8000 customers which utilize the Clincial Chemistry Multiconstituent Calibrator on December 27,2005. Outside the U.S. each country organization will need to determine the appropriate method for the effectiveness check.