Z-2323-2012 Class III Terminated
FDA device recall Z-2323-2012 was initiated by Trek Diagnostic Systems on Jul 23, 2012 and is designated Class III. Reason for recall: Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling bottle from the Vers… The recall status is terminated (terminated Jun 18, 2013). Affected quantity: 333 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 12, 2012
- Initiation Date
- Jul 23, 2012
- Termination Date
- Jun 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 333 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA including AL, AR, AZ, CA, CO , CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV, and WY. Internationally to the countries of Bahamas, Bangladesh, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, India, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Pakistan, Peru, Philippines, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Thailand, Turkey, and United Kingdom