Drew Scientific Group PLC Recalls

FDA
2
Total Recalls
1
Agencies
Mar 2008
First Recall
Mar 2008
Latest Recall
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Showing 1-2 of 2 recalls

FDA

Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.

System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.

Firm sent 'Technical Bulletin #39' to all customers on 09/20/06. Users advised of potential for inaccurate readings and provided with instructions on how to eliminate problem.
FDA

Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.

Flags and alerts on the user interface will not automatically transfering to the LIS.

Firm sent 'Product Notification #22' to all customers on 08/24/06. Users advised of potential risk to patient health and provided with instructions on how to eliminate risk by disabling the auto transfer feature and manually transfering data until a software patch is made available