Company:Beckman Coulter Inc.
Date of Enforcement Report 3/17/2010
Class:l
PRODUCT
1) Coulter LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample Flow, Part Number 6605633, P/N 4277248, 4277299, and 277299. Intended for use as an optional peripheral to the Beckman Coulter LH 700 Series System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the LH 700 Series. Recall # Z-0850-2010;
2) GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and Sample, Part Numbers 6605360, P/N 4237221, 4237212, and 4277299. Intended for use as an optional peripheral to the COULTER GEN*S System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the GEN*S System. Recall # Z-0851-2010
REASON
The Sample ID information embedded in the barcode affixed to a slide made by the Coulter GEN*S and LH SlideMaker does not match the text.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated June 9, 2008.
Manufacturer: Beckman Coulter Inc., Fullerton, CA. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
847 units
DISTRIBUTION
Nationwide and Canada
