CLINICAL CHEMISTRY AST-ACTIVATED
Received Apr 26, 2007 · Event occurred Apr 4, 2007
Report 2018433-2007-00004 · MDR key 958407
Device
Generic name
Quantitation Of Aspartate Aminotransferase
Manufacturer
Abbott Laboratories, IncModel number
NACatalog number
8D37-30
Lot number
46059HW00
Product problems
- Mislabeled
- Nonstandard Device
Patient
NO INFO
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
TO DATE SEVEN CUSTOMER COMPLAINTS (INTERNATIONAL AND OTHER COUNTRY) WERE RECIEVED FOR AST-ACTIVATED REAGENT (LIST 08D37-30; LOT 46059HW00) WITH REAGENT CARTRIDGES CONTAINING AN INCORRECT TOP LABEL WITH THE PRODUCT SHORT-NAME ALTA INSTEAD OF ASTA. CUSTOMER MAY FIND AN AST ACITVATED REAGENT CARTRIDGE WITH AN INCORRECT TOP LABEL WITH THE PRODUCT SHORT-NAME ALTA INSTEAD OF ASTA. TWO SCENARIOS MAY OCCUR WHEN A CUSTOMER ENCOUNTERS THIS CARTRIDGE LABELING ISSUE: IN SCENARIO # 1- THE CUSTOMER RUNS ASSAY USING REAGENT BARCODE LABEL AS ASTA. NO IMPACT ON RESULTS. IN SCENARIO # 2- THE CUSTOMER MISTAKENLY RUNS ALTA REAGENT IN THIS ASTA CARTRIDGE. RESULTS OBTAINED MAY BE HIGH OR LOW AND REPORTED AS ASTA NOT REPORTED AS ALTA. A RECALL WAS ISSUED AND REPORTED TO THE FDA. ABBOTT HAS NOT RECIEVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THIS ISSUE.
Additional Manufacturer Narrative
THIS IS A FINAL REPORT.