Z-0473-2021 Class II Terminated
FDA device recall Z-0473-2021 was initiated by Siemens Healthcare Diagnostics, Inc. on October 26, 2020 and is designated Class II. Reason for recall: Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version… The recall status is terminated (terminated April 19, 2024). Affected quantity: US 392 units; OUS 449 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- October 26, 2020
- Termination Date
- April 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US 392 units; OUS 449 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Poland, Portugal, Qatar Republic, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay, Vatikancity, Vietnam.