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Dimension Magnesium Test (Siemens) – Quality Control Problem (2022)

Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur

Moderate

FDAAug 17, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Great Value Chopped Walnuts (South Georgia) – mislabeled product (2022)

The firm stated that pecan pieces were packaged in pouches labeled as walnuts.

Class IIModerate

FDAAug 17, 2022FL, IN, NC• South Georgia Pecan Company

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Dimension Magnesium Test (Siemens) – Quality Control Problem (2022)

Great Value Chopped Walnuts (South Georgia) – mislabeled product (2022)

Bentson Wire Guide (Cook) – Packaging Seal Breach (2022)

Roadrunner PC Wire Guide (Cook) – Packaging Seal Breach (2022)

Roadrunner PC Hydrophilic Guide (Cook) – Packaging Seal Breach (2022)

Roadrunner PC Firm Wire Guide (Cook) – Packaging Seal Breach (2022)

Double Flexible Wire Guide (Cook) – Packaging Seal Breach (2022)

Cope Mandril Steel Guide (Cook) – Packaging Seal Breach (2022)

Fixed Core Wire Guide (Cook) – Packaging Seal Breach (2022)

Heavy Flexible Wire Guide (Cook) – Packaging Seal Breach (2022)

Bentson Distal Flexibility Guide (Cook) – Packaging Seal Breach (2022)

ConvaTec Esteem+ Durahesive Plus Pouch (ConvaTec) – Liner Functionality (2022)

Fixed Core Wire Guide (Cook) – Packaging Seal Breach (2022)

Active Life Pouch (ConvaTec) – Release Liner Problem (2022)

Coons Interventional Wire Guide (Cook) – Packaging Seal Breach (2022)

Rosen Curved Wire Guide (Cook) – Packaging Seal Breach (2022)

Bentson Plus Wire Guide (Cook) – Packaging Seal Breach (2022)

Lunderquist Ring Torque Guide (Cook) – Packaging Seal Breach (2022)

Movable Core Wire Guide (Cook) – Packaging Seal Breach (2022)

Torq-Flex Wire Guide (Cook) – Packaging Seal Breach (2022)