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BAYER ADVIA RECALL
For those of you not accessing the BioFind Rumor Mill on a regular basis, we pulled this from one of the messages about an Advia Recall. This lists all the Recalls that the Advia has experienced.
#Z-1073/1074-9
REASON: When running the 120 system in the manual mode using the Host Query feature, and the timeout is set to 13 second, it is possible for the system to report incorrect patient results...
#Z-1075/1076-9
REASON: The sample needle can be activated while the system is in stand-by mode during needle chamber cleaning procedure. Product labeling warns that the system must be either off or in the stand-by mode to perform routine maintenance, or personal injury
from the may occur...
#Z-869/870-9
REASON: The device may give erroneous results because of the valve gasket deterioration in the Baso channel check valve, and the software designed will not flag significant discrepancies in the results between the two methodologies at extremely low counts...
#Z-615/616-9
REASON: The device may give false red blood cell and blood platelet counts...
#Z-810-0
ENFORCEMENT REPORT FOR JULY 5, 2000
CODE: All serial numbers
REASON: Higher than expected percentage Reticulocyte counts were received, due to carryover from one sample to another... (See below)
PRODUCT Recall #Z-810-0
Bayer Advia 120 Automated Hemotology System, Model 120, a quantitative automated hematology analyzer that provides a leukocyte, differential count and reticulocyte analysis for in vitro diagnostic use in clinical laboratories..
CODE
All serial numbers.
MANFACTURER
Bayer Diagnostics Mfg. Ltd., Swords, Co. Dublin, Ireland.
RECALLED BY
Bayer Corporation, Elkhart, Indiana, by letter dated May 2000. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
1,800 units were distributed.
REASON
Higher than expected percentage Reticulocyte counts were received, due to carryover from one sample to another.
If you have a customer who is enamoured of the Advia, you should direct them to discuss the recalls listed with their Bayer rep before further consideration of the Advia. | 
