FDA-Device2022-05-04Class II
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
Siemens Healthcare Diagnostics, Inc.
Hazard
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN, MN, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WI, WY and OUS: 81 countries.
Affected count
10,755 boxes (533 US, 10,222 OUS)
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1015-2022Don't want to check this manually?
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