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Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Recalled June 23, 2021 · FDA recall Z-1870-2021 · Siemens Healthcare Diagnostics
Hazard
Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results · FDA Class II
Units
2,153 units
Sold at
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.
Description
Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
Product
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →