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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
BD MAX (tm) (6 channel) Instruments		see related information
Date Posted January 22, 2013
Recall Number Z-0701-2013
Product Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
Code Information Serial Numbers: MX0001 to MX0065 CM0001 to CM0105 NOTE: Serial numbers are assigned sequentially. The above ranges will include all sequential numbers in between the beginning and end points.
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks, Maryland 21152-0999
For Additional Information Contact Gail Claiborne
410-316-4054
Reason for
Recall		 Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.
Action Becton Dickinson sent an Urgent Field Corrective Action letter September 18, 2012,by fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that BD Field Service Associates will contact them within 7-10 days of the notification to determine if their instrument is impacted. Customers were requested to return a response form indicating the serial number on their instrument. If customers needed further assistance they were instrycted ti contact BD Technical Services Department at 1-800-638-8663. For questions regarding this recall call 410-316-4054.
Quantity in Commerce 86 Instruments
Distribution USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.
 
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