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QMS Tacrolimus Calibrator (Microgenics) – Value Recovery Issue (2022)

Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.

FDAJan 20, 2022AL, AZ, CA +18 more• Microgenics Corporation

Adult Lumbar Puncture Drug Free Tray (Bard) – Manometer Failure (2022)

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

FDAJan 20, 2022Nationwide• Bard Peripheral Vascular Inc

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QMS Tacrolimus Calibrator (Microgenics) – Value Recovery Issue (2022)

Adult Lumbar Puncture Drug Free Tray (Bard) – Manometer Failure (2022)

Safe-T Plus Lumbar Puncture Tray (Bard) – Manometer Failure (2022)

Sight OLO Blood Analysis Device (Sight Diagnostics) – Reference Range Issue (2022)

Pediatric Lumbar Puncture Tray (Bard) – Manometer Failure (2022)

Lumbar Puncture Tray Adult (Bard) – Manometer Failure (2022)

Safe-T Plus Lumbar Puncture Tray (Bard) – Manometer Failure (2022)

Lumbar Puncture Tray Adult (Bard) – Manometer Failure (2022)

Safe-T Plus Atraumatic LP Tray (Bard) – Manometer Failure (2022)

Atraumatic Lumbar Puncture Tray (Bard) – Manometer Failure (2022)

Lumbar Puncture Tray Pediatric (Bard) – Manometer Failure (2022)

SyncVision Systems (Volcano) – Measurement Calculation Error (2022)

ACUSON Juniper Ultrasound (Siemens) – Clip Store Malfunction (2022)

LINQ II Cardiac Monitor (Medtronic) – Moisture Ingress Risk (2022)

Opaque Herrick Lacrimal Plugs (Lacrimedics) – Pouch Seal Issue (2022)

Collagen Plugs (Lacrimedics) – Pouch Seal Issue (2022)

CIRRUS HD-OCT Angioplexs (Carl Zeiss) – Scan Clearance Issue (2022)

1688 Camera Control Unit (Stryker) – Image Orientation Defect (2022)

Biolox Delta Ceramic Femoral Head (Howmedica) – Size Labeling Error (2022)

Everest MI XT Outer Dilator (Unknown) – Fitting Problem (2022)