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U.S. Department of Health and Human Services

Class 2 Device Recall ABBOTT Clinical Chemistry Multiconstituent Calibrator List number: lE6502

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 Class 2 Device Recall ABBOTT Clinical Chemistry Multiconstituent Calibrator List number: lE6502see related information
Date Initiated by FirmDecember 23, 2005
Date PostedFebruary 14, 2006
Recall Status1 Terminated 3 on April 24, 2012
Recall NumberZ-0516-06
Recall Event ID 34435
510(K)NumberK981706 
Product Classification Calibrator, Multi-Analyte Mixture - Product Code JIX
ProductClinical Chemistry Multiconstituent Calibrator--- List number: lE65-02
Code Information Lot number(s): 19906M200 (expiration date 02/28/2006), 20879MIOO (expiration date 02/28/2006), & 26674MIOO (expiration date 07/31/2006)
FEI Number 2018433
Recalling Firm/
Manufacturer		 Abbott Laboratories Diagnostic Div
820 Mission St
South Pasadena CA 91030-3142
For Additional Information ContactMark Littlefield
972-518-6062
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionA 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.
Quantity in Commerce13961
DistributionNationwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JIX
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