FDA recall Z-1015-2022

Siemens Healthcare Diagnostics, Inc. · Class II · device

Product

IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]

Reason for recall

Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2022-02-22
Report date
2022-05-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1015-2022