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BioFire BCID2 Panel (BioFire) – Temperature Excursion (2023)

Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.

Moderate

FDAFeb 1, 2023Nationwide• BioFire Diagnostics, LLC

MicroVue C1-Inhibitor EIA (Quidel) – Low OD Values (2023)

Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

Low

FDAFeb 1, 2023Nationwide• Quidel Corporation

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BioFire BCID2 Panel (BioFire) – Temperature Excursion (2023)

MicroVue C1-Inhibitor EIA (Quidel) – Low OD Values (2023)

BD Ultra-Fine II Insulin Syringe (BD) – Nonsterile Risk (2023)

BD Insulin Syringe (BD) – Nonsterile Risk (2023)

Genesis Reusable Container (Carefusion) – Sterility Breach (2023)

DRX-Compass X-ray System (Carestream) – Tube Movement (2023)

Fusion Bioline Vascular Graft (Maquet) – Lot Intermixing (2023)

Simplexa COVID-19 Direct (DiaSorin) – Disc Leakage (2023)

Dimension Tacrolimus Flex (Siemens) – Imprecision Issue (2023)

Atropine Sulfate Eye Solution (Akorn) – Failed Stability (2023)

Delsam Artificial Tears (Global Pharma) – CGMP Deviation (2023)

Artificial Tears Eye Drops (Global Pharma) – Bacterial Contamination (2023)

Artificial Tears Eye Drops (Global Pharma) – CGMP Deviation (2023)

Delsam Artificial Tears (Global Pharma) – Bacterial Contamination (2023)

Simplexa Flu A/B & RSV Kit (DiaSorin) – Disc Leakage (2023)

Atellica CH Triglycerides (Siemens) – Reagent Carryover (2023)

Atellica CH Total Protein II (Siemens) – Reagent Carryover (2023)

Atellica CH Triglycerides_2 (Siemens) – Reagent Carryover (2023)

Atellica CH LDL Cholesterol (Siemens) – Reagent Carryover (2023)

Access Immunoassay Systems (Beckman Coulter) – Nut Band Damage (2023)