Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
This recall has been terminated (originally issued January 22, 2013).
- Recall Initiated
- September 18, 2012
- Posted
- January 22, 2013
- Terminated
- February 4, 2013
- Recall Number
- Z-0701-2013
- Quantity
- 86 Instruments
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.
Distribution
USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.