Recall Z-1820-2022 ยท JZO System, Test, Thyroid Autoantibody
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
| Date | Sep 27, 2022 (initiated Aug 11, 2022) |
| Status | Open, Classified |
| Reason | An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthcare issued an "Urgent Medical Device Correction (UMDC IMC 22-09.A.US)" to US customers, and an "Urgent Field Safety Notice (UFSN IMC 22-09.A.OUS)" to Outside the US (OUS) customers. The UMDC and UFSN letters provide instructions to customers to follow: When this issue occurs, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid. Mitigations would include correlation of tests results with additional tests such as anti-TPO antibodies along with thyroid function tests such as total T3 and T |
| Quantity | 100 units US; 328 units OUS |
| Distribution | Worldwide Distribution: US (nationwide) to states of: FL IN MA MI NH NJ NY OH TX UT and OUS (Foreign) countries of: Aus |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material Siemens Healthcare Diagnostics, Inc., Mar 3, 2016 |