Z-1870-2021 Class II Ongoing
FDA device recall Z-1870-2021 was initiated by Siemens Healthcare Diagnostics, Inc. on May 4, 2021 and is designated Class II. Reason for recall: Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results The recall status is ongoing. Affected quantity: 2,153 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 23, 2021
- Initiation Date
- May 4, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,153 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Colombia, Croatia Cura¿ao, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, P.R. China Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Uganda, United Kingdom, Uruguay, Vatikancity, Vietnam.