Company: Biochem Immunosystems (U.S.), Inc
Date of Enforcement Report: 1/23/02
Class: II
PRODUCT
Personal Lab Version 2.2a. The device is an Immunochemistry Analyzer Open System, Recall # Z-0463-02.
REASON
Samples were not picked up and added to the dilution tube.
CODE
Version 2.2a Catalog # PL01.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biochem Immunosystems (U.S.), Inc. Allentown, PA, by sending software correction diskettes and notifications on Aug. 15 and by telephone on Aug. 16, 2001. Manufacturer: BioChem ImmunoSystems Italia Spa Guidonia Montecello, Rome. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
Nationwide.