Z-1255-2017 Class II Terminated
FDA device recall Z-1255-2017 was initiated by Siemens Healthcare Diagnostics, Inc on January 10, 2017 and is designated Class II. Reason for recall: Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT System… The recall status is terminated (terminated July 16, 2019). Affected quantity: 1937 kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2017
- Initiation Date
- January 10, 2017
- Termination Date
- July 16, 2019
- Voluntary/Mandated
- N/A
- Product Quantity
- 1937 kits
Product Description
Reason for Recall
Distribution Pattern
Nationwide. Afghanistan, Albania, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vatican, Vietnam