FDA Device

Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas

Hazard

ICT assays run using a manual dilution will not be calculated correctly by the software.

What You Should Do

Remedy

Product Information letter dated 29 December 2000 was sent to all AEROSET customers.

Products

Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas
Brand
Abbott Laboratories, Inc
UPC
All units

Units Affected

143