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NextSeq 550Dx (Illumina) – potential short circuit (2022)

There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.

FDAFeb 22, 2022AL, AZ, AR +28 more• Illumina, Inc.

ACL TOP Hemostasis Analyzer (Instrumentation) – carryover quality control (2022)

Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe

FDAFeb 22, 2022Nationwide• Instrumentation Laboratory

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NextSeq 550Dx (Illumina) – potential short circuit (2022)

ACL TOP Hemostasis Analyzer (Instrumentation) – carryover quality control (2022)

Liko Universal Twinbar (Baxter) – incorrect center bolt (2022)

Gammex Non-Latex Surgical Gloves (Ansell) – border inspection failure (2022)

Cardiohelp-i Transport Guard (Maquet) – locking mechanism risk (2022)

ORAcollect RNA (DNA Genotek) – liquid evaporation issue (2022)

SIGNA Excite 3T (GE Healthcare) – image flipping risk (2022)

SIGNA Excite HD (GE Healthcare) – image flipping risk (2022)

NeuMoDx Cartridge (NeuMoDx) – SARS-CoV-2 false positive (2022)

SIGNA HDx/HDxt (GE Healthcare) – image flipping risk (2022)

Signa 1.5T TwinSpeed (GE Healthcare) – image flipping risk (2022)

Medical Devices (Dollar Tree) – rodent exposure risk (2022)

OTC Drug Products (Dollar Tree) – Rodent Exposure Risk (2022)

ORAcollect Dx (DNA Genotek) – liquid evaporation issue (2022)

Similac Human Milk Fortifier (Abbott) – bacterial contamination (2022)

Similac Organic A2 Milk Toddler Drink (Abbott) – bacterial contamination (2022)

EleCare Jr Amino Acid Nutrition Powder (Abbott) – bacterial contamination (2022)

EleCare Jr Unflavored Nutrition Powder (Abbott) – bacterial contamination (2022)

Similac Spit Up Infant Formula (Abbott) - Bacterial Contamination (2022)

Similac Pro-Advance (Abbott) – Bacterial Contamination (2022)