2/21/00 Class II
PRODUCT
Aeroset Analyzer, used for in-vitro diagnostic tests.
Recall #Z-489-0.
REASON
Under certain washing conditions, software error causes erratic urine creatinine results.
CODE
All Codes.
MANUFACTURER
Abbott Laboratories, Inc., Irving, Texas.
RECALLED BY
Manufacturer, by letter dated February 21, 2000.
Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
176 analyzers were distributed.
Being Agile & Yet Compliant (Public)
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2-days onsite with group exercises, quizzes, examples, Q&A.
Instructor: Dr Peter Rech, 2nd instructor (optional)
Next public offering: TBD
