Immulite 2000 Sytstem Thyroglobulin Assay
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Immulite 2000 Sytstem Thyroglobulin Assay |
436 |
L2KTY2 |
Issue
Siemens Healthcare Diagnostics Inc. has confirmed through customer complaints the potential for functional sensitivity to not meet instructions for use (IFU) claims with the kit lots listed in table 1. Additionally, immulite thyroglobulin control module control level one may result outside of the published ranges. Per good laboratory practice, patient results are not reported when controls result out of range.
Recall start date: December 15, 2022
Additional information
Details
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy, Llanberis, Gwynedd, Great Britain, LL55 4EL
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