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IMMULITE 2000 Thyroglobulin (Siemens) – Sensitivity Issue (2022)

Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples

Moderate

FDADec 7, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

IMMULITE 2000 Thyroglobulin (Siemens) – Sensitivity Issue (2022)

Moderate

FDADec 7, 2022Nationwide

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IMMULITE 2000 Thyroglobulin (Siemens) – Sensitivity Issue (2022)

IMMULITE 2000 Thyroglobulin (Siemens) – Sensitivity Issue (2022)

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Single-Use Packs (Johnson & Johnson) – Weld Protrusion (2022)

Large Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)

Garbin Ventilator (Philips) – Foam Separation (2022)

Large Rotating Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)

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NexGen Tibial Component (Zimmer) – Surgical Component Issue (2022)