Terminated

Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02

FDA Recall Z-0516-06 · Posted 2006-02-14

Recalling FirmAbbott Laboratories Diagnostic Div

Recall StatusTerminated

Product CodeJIX

Date Initiated2005-12-23

Date Terminated2012-04-24

Product Quantity13961

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981706AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2Abbott Laboratories · 1998-07-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.