Abbott Laboratories Diagnostic Div Recalls
Showing 1-11 of 11 recalls
Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
Precipitate formed in product.
Firm sent recall letters requesting destruction of kits in the field on July 27, 2004.
Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02
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.
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.
Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100
The product issue is that the value sheet for the Clinical Chemistry Bilirubin Calibrator, lot #20881M100 calibrator value sheet, has the calibrator values transposed for the Total Bilirubin Assay LN 7D60, Total Bilirubin Assay LN 8G62, and Neonatal Bilirubin Assay LN 9D88.
A Device Correction letter correcting the transposition of the calibrator values dated August 5, 2005, was mailed to all customers receiving the Clinical Chemistry Bilirubin Calibrator, LN 1E66-03, Lot Number 20881M100.
Clinical Chemistry Uric Acid; LN 7D76-20
Unacceptable upward drift of results in control runs within 24 hour period.
Firm sent recall letters 3/18/2004 suggesting destruction and/or running QC tests every eight hours instead of every 24 hours as is in labeling.
Clinical Chemistry Urea Nitrogen
Low results due to contaminant.
Each domestic customer will receive the recall letter by direct mailing. Foreign affiliates will be responsible for distributing letters to thier customers. Letters were sent 11/24/2003. A reply form was enclosed.
AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30
False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.
Firm sent letter to customers dated November 24,2003 which includes a new package insert to use with this reagent. Instructions were changed to correct low resulting situation. Subrecall was requested.
Clinical Chemistry Apolipoprotein A1, List Number 9D92-20
These specific protein assays are not meeting the 57-day on board stability claim
A Device Correction letter identifying the changes being made to the frequency of QC monitoring for these assays, will be distributed to all AEROSET and ARCHITECT c8000 customers which utilize the IgM, Prealbumin and Apolipoprotein Al Specifc Protein assays on November 10,2005 via direct mailing. Outside the U.S. each country organization will need to determine the appropriate method for the effectiveness check..
Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.
Complaints that instructions for use were not clear.
Firm sent customer letters dated 12/22/2003 which included updated instructions for use.