IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
FDA Recall Z-1015-2022 · Posted None
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeDHA
Date Initiated2022-02-22
Product Quantity10,755 boxes (533 US, 10,222 OUS)
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.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.