Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6] Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

Urgent Medical Device Correction was issued February 02, 2022 via Fed Ex. Notification provides instructions to customers to mitigate this sample carryover. Customers are requested to complete and return the Effectiveness Check questionnaire. Contact your local Siemens Healthineers technical support representative with any questions.