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Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnost... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from AtellicaCH Total Bilirubin_2 (TBil_2), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)

Moderate

FDAJul 10, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica CH LDL Cholesterol- In vitro diagnostic use in t... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)

Moderate

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Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnost... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Atellica CH LDL Cholesterol- In vitro diagnostic use in t... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

SPICER DRIVESHAFT – dana incorporated (dana) is recalling... (2023)

2022 BOREAS CAMPER XT – fire hazard (2023)

2022 YAMAHA TENERE 700 – yamaha motor corporation, usa (yamaha... (2023)

SurgiCount+ Software Application-indicated as an adjuncti... (Stryker Corporation) – potential for current software to mis... (2023)

Hand Sanitizer (Big Machine Distillery) – Impurity Excess (2023)

2024 BMW X5 – bmw of north america, llc (bmw) is re... (2023)

Atellica CH Total Bilirubin_2 -In vitro diagnostic use in... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

Five S 5 3x65, REF: 0915612-06, sterile for single use, S... (Karl Storz Endoscopy) – flexible intubation endoscopes steri... (2023)

Procedural kits containing ultrasonic transmission gel, I... (Advance Medical Designs, Inc.) – mislabeling (2023)

IRONMAN 4X4 PRO FORGE – ironman 4x4 usa ii llc (ironman) is r... (2023)

2023 TOYOTA TUNDRA HYBRID – toyota motor engineering & manufactur... (2023)

ASG-001; Ultrasound gel (Advance Medical Designs, Inc.) – mislabeling (2023)

2019 NEWMAR BAY STAR – newmar corporation (newmar) is recall... (2023)

50-GEL20; Ultrasound gel (Advance Medical Designs, Inc.) – mislabeling (2023)

LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP Sys... (Alphatec Spine, Inc. 1950 Camino Vida Roble) – awl instrument adjustable drill butto... (2023)

woom ORIGINAL Bicycles (woom Bikes) – Fall risk (2023)

TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only (Johnson & Johnson Surgical Vision, Inc.) – their is a potential that intraocular... (2023)

300 Series Snow Blowers (Husqvarna) – Injury hazard (2023)