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PRODUCT
1) Mikro 12-24 Centrifuge with 2050 Rotor TYP #2070 and TYP 2070-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured. Recall Z-0612-2010;
2) Haematokrit 24 Centrifuge with 2050 Rotor TYP #2075 and TYP #2075-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured. Recall # Z-0613-2010;
3) Mikro 20 Centrifuge with 2076 Rotor TYP #2004 and TYP #2004-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured. Recall # Z-0614-2010;
4) Haematokrit 20 Centrifuge with 2050 Rotor TYP #2014-01 and TYP#201424-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured. Recall # Z-0615-2010
CODE
1) Units with plastic motor housing. TYP #2070 and TYP 2070-01;
2) Units with plastic motor housing. TYP #2075 and TYP #2075-01;
3) Units with plastic motor housing. TYP #2004 and TYP #2004-01;
4) Units with plastic motor housing. TYP #2014-01 and TYP#201424-01
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hettich Instruments Management I, Beverly, MA, by email on November 21, 2009, and by letter dated November 23, 2009.
Manufacturer: Andreas Hettich Gmbh & Co. Kg, Tuttlingen, Germany. Firm initiated recall is ongoing.
REASON
Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge.
VOLUME OF PRODUCT IN COMMERCE
46 units
DISTRIBUTION
Nationwide and Canada |
