Abbott Laboratories Diagnostic Div Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02
Brand
Abbott Laboratories Diagnostic Div
Lot Codes / Batch Numbers
Lot number(s): 19906M200 (expiration date 02/28/2006), 20879MIOO (expiration date 02/28/2006), & 26674MIOO (expiration date 07/31/2006)
Products Sold
Lot number(s): 19906M200 (expiration date 02/28/2006), 20879MIOO (expiration date 02/28/2006), & 26674MIOO (expiration date 07/31/2006)
Abbott Laboratories Diagnostic Div is recalling Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02 due to The two Multiconstituent Calibrator (MCC) lot numbers 19906M200 and 20879M100 failed to meet product performance expectations throughout the labeled e. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026