Z-0516-06

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

Name: Z-0516-06 Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02
Creator: Abbott Laboratories Diagnostic Div
Published: 2005-12-23
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-12-23 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories Diagnostic Div began a recall of Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02 on 2005-12-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0516-06
Status: Terminated
Initiated: 2005-12-23
Posted: 2006-02-14
Terminated: 2012-04-24
Recalling firm: Abbott Medical
Product: Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02
Product code: JIX Calibrator, Multi-Analyte Mixture
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.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 13961
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.
Product codes and lots: Lot number(s): 19906M200 (expiration date 02/28/2006), 20879MIOO (expiration date 02/28/2006), & 26674MIOO (expiration date 07/31/2006)

Product code JIX

K981706Class IIAmm Cal, Bil Cal, CO2 Cal, Hdl Cal, Iron/mg Cal, Ldl Cal, Mc Cal, Upro Cal, and Ise Calibrator Levels 1 and 2Abbott Laboratories / cleared 1998-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)