Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Class IIModerate

FDAOct 20, 2023IN, PR• Omega & Delta Co., Inc.

epoc NXS Host Blood Analysis (Siemens) – software error (2023)

Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. The worst possible outcome may result in a failure to diagnose hyperkalemia, due to an erroneous depressed potassium level or inappropriate treatment to hyperglycemia due to erroneous glucose reading.

High

FDAOct 19, 2023Nationwide• Siemens Healthcare Diagnostics Inc

CELL-DYN Ruby (Abbott) – undeclared latex (2023)

The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

Moderate

FDAOct 19, 2023AL, AZ, AR +35 more• Abbott Laboratories

Controller 97745 (Medtronic) – firmware issue (2023)

Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.

Low

FDAOct 19, 2023Nationwide• Medtronic Neuromodulation

Leg Bag (Medline) – undeclared latex (2023)

Undeclared Allergen

Undeclared latex

Moderate

FDAOct 19, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Para-Pak Zn-PVA (Meridian) – leakage risk (2023)

Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.

High

FDAOct 19, 2023Nationwide• Meridian Bioscience Inc

ARCHITECT c4000 Processing Module (Abbott) – undeclared latex (2023)

The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

Moderate

FDAOct 19, 2023AL, AK, AZ +45 more• Abbott Laboratories

Combo Kit (Integra) – packaging defect (2023)

Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device

High

FDAOct 19, 2023Nationwide• Integra LifeSciences Corp.

Cranial Access Kit (Integra) – packaging defect (2023)

Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device

High

FDAOct 19, 2023Nationwide• Integra LifeSciences Corp.

Modular Cooler-Heater (CardioQuip) – heater malfunction (2023)

Fire/Burn Risk

There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.

High

FDAOct 19, 2023AL, CA, CT +12 more• CardioQuip, LLC

Cranial Access Kit (Integra) – packaging defect (2023)

Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device

High

FDAOct 19, 2023Nationwide• Integra LifeSciences Corp.