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Atellica CH Total Bilirubin_2 -In vitro diagnostic use in... (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), AtellicaCH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and AtellicaCH HDL Cholesterol (HDLC)

Low

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

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

Flexible intubation endoscopes sterility assurance can not be confirmed.

High

FDAJul 7, 2023Nationwide

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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)

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

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

Access Thyroglobulin Calibrators (Beckman Coulter, Inc.) – it has been determined through an int... (2023)

Medtronic InterStim Ground Pad REF 041826 (Medtronic Neuromodulation) – lot of interstim self-adhesive ground... (2023)

SofTech Pressure-Sensing Wheelchair Cushions (Aquila Corporation) – defective battery pack in wheelchair ... (2023)

APK2 Pressure-Sensing Wheelchair Cushions (Aquila Corporation) – defective battery pack in wheelchair ... (2023)

TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00,... (Johnson & Johnson Surgical Vision, Inc.) – their is a potential that intraocular... (2023)

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size ... (Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany) – increased force may be required to re... (2023)

Total Hip Kit, REF DYNJ903275S; surgical convenience kit (MEDLINE INDUSTRIES, LP Northfield) – the prep solution included in the tot... (2023)

LifeSPARC Pump (part number 5800-0000) contained within T... (Cardiac Assist, Inc) – epoxy used during manufacturing of th... (2023)

Wireless Foot Switch distributed with Philips Allura Xper... (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands) – loss of availability of the wireless ... (2023)

3D9-3v Transducer, accessory to Philips Ultrasound System... (Philips Ultrasound, Inc.) – shock hazard (2023)

Impella RP Flex with SmartAssist intracardiac microaxial ... (Abiomed, Inc.) – a higher than expected rate of throm... (2023)

MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 c... – catheter center lumen was found to ha... (2023)

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis ... – catheter center lumen was found to ha... (2023)