Z-0701-2013 Class II Terminated
FDA device recall Z-0701-2013 was initiated by Becton Dickinson & Co. on Sep 18, 2012 and is designated Class II. Reason for recall: Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results. The recall status is terminated (terminated Feb 4, 2013). Affected quantity: 86 Instruments.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 30, 2013
- Initiation Date
- Sep 18, 2012
- Termination Date
- Feb 4, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 86 Instruments
Product Description
Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
Reason for Recall
Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.
Distribution Pattern
USA including CT, FL, IL, KS, MD, MI, MO, NY, PA, RI, TX and WI. Internationally to Canada, Europe and Japan.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0701-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026