Z-1226-2017 Class II Terminated
FDA device recall Z-1226-2017 was initiated by BioMerieux SA on January 18, 2017 and is designated Class II. Reason for recall: Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods. The recall status is terminated (terminated January 30, 2020). Affected quantity: 7,160 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 1, 2017
- Initiation Date
- January 18, 2017
- Termination Date
- January 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,160 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US including AZ, AR, CA, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WV, WI, and Internationally to Algeria, United Arab Emirates, Austria, Australia, Brazil, Cambodia, Canada, Chile, Chine, Costa Rica, Croatia, Czech Republic, Ecuador, Estonia, France, Greece, Germany, Great Britain, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, Nigeria, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Uruguay, and Vietnam