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Atellica CH Fructosamine (Siemens) – Reagent Carryover (2022)

Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

FDAFeb 9, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH Lithium_2 (Siemens) – Reagent Carryover (2022)

Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

FDAFeb 9, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

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Atellica CH Fructosamine (Siemens) – Reagent Carryover (2022)

Atellica CH Lithium_2 (Siemens) – Reagent Carryover (2022)

VIDAS CMV IgM (bioMerieux) – Invalid Calibrations (2022)

Atellica CH Calcium_2 (Siemens) – Reagent Carryover (2022)

Atellica CH Hemoglobin A1c (Siemens) – Reagent Carryover (2022)

Ultima Activator II Drive Mechanism (Maquet) – Potential Corrosion (2022)

BioPlex 2200 Syphilis Pack (Bio-Rad) – Vaccine Interference (2022)

BioPlex 2200 Syphilis Calibrator (Bio-Rad) – Vaccine Interference (2022)

Autoclavable Temperature Probes (Philips) – Cleaning Update (2022)

Smart Pads Cartridge Adult (Philips) – Gel Separation (2022)

Smart Pads Cartridge Infant/Child (Philips) – Gel Separation (2022)

Alinity s System (Abbott) – Wash Buffer Error (2022)

Touch Screen Module (Volcano) – Potential Cracking (2022)

Philips Allura (Philips) – Software Image Processing (2022)

NuOss Collagen Block (Ace Surgical) – Packaging Mixup (2022)

Mevion Proton Therapy System (Mevion) – Hand Pendant Malfunction (2022)

STANDARD Q COVID-19 Ag Home Test (SD Biosensor) – Unauthorized Import (2022)

INFX-8000V (Canon Medical) – Fluoroscopic Dose Rate (2022)

Ysiosystem (Siemens) – Software Processing Error (2022)

Dimension Vista Magnesium Flex (Siemens) – Reagent Imprecision (2022)