Recall Z-1015-2022 ยท DHA System, Test, Human Chorionic Gonadotropin
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]
| Date | Feb 22, 2022 |
| Status | Open, Classified |
| Reason | Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors. |
| Root cause | Under Investigation by 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. |
| Quantity | 10,755 boxes (533 US, 10,222 OUS) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990222 | IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6 Diagnostic Products Corp., Feb 26, 1999 |