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Showing 6821–6840 of 11714 results

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Fingolimod Capsules (Ascend) – dissolution failure (2023)

Failed Dissolution Specifications

Class IIModerate

FDAJul 11, 2023Nationwide• Ascend Laboratories, LLC

Oxacillin Injection (Sagent) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Atellica CH HDL Cholesterol- 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), 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 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)

Moderate

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

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

Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type

Low

FDAJul 10, 2023Nationwide• Stryker Corporation

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

CGMP Deviation: impurities exceed allowable limits.

Class IIModerate

FDAJul 10, 2023TN• Tenn South Distillery LLC dba Big Machine Distillery

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• Karl Storz Endoscopy

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

Ultrasound gel mislabeled with inappropriate use.

Low

FDAJul 7, 2023Nationwide• Advance Medical Designs, Inc.

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

Ultrasound gel mislabeled with inappropriate use.

Low

FDAJul 7, 2023Nationwide• Advance Medical Designs, Inc.

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

Ultrasound gel mislabeled with inappropriate use.

Low

FDAJul 7, 2023Nationwide• Advance Medical Designs, Inc.

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)

Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.

High

FDAJul 7, 2023Nationwide• Alphatec Spine, Inc. 1950 Camino Vida Roble

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

Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

Moderate

FDAJul 6, 2023Nationwide• Johnson & Johnson Surgical Vision, Inc.

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

It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.

Low

FDAJul 6, 2023Nationwide• Beckman Coulter, Inc.

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

Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.

Low

FDAJul 6, 2023Nationwide• Medtronic Neuromodulation

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

Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.

High

FDAJul 6, 2023Nationwide• Aquila Corporation

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

Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.

Moderate

FDAJul 6, 2023Nationwide• Aquila Corporation

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

Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

Moderate

FDAJul 6, 2023Nationwide• Johnson & Johnson Surgical Vision, Inc.

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)

Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

Moderate

FDAJul 3, 2023Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

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