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

Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.

FDAJan 13, 2022Nationwide

Luscient COVID-19 Antigen Test (Lusys) – Unauthorized Distribution (2022)

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

FDAJan 13, 2022Nationwide• Lusys Laboratories, Inc.

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

Luscient COVID-19 Antigen Test (Lusys) – Unauthorized Distribution (2022)

COVID-19 Antibody Test (Lusys) – Unauthorized Distribution (2022)

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

SonialVision Safire17 X-Ray (Shimadzu) – Radiation Dose Issue (2022)

FLUOROspeed X1 X-Ray System (Shimadzu) – Radiation Dose Issue (2022)

SonialVision G4 X-Ray System (Shimadzu) – Radiation Dose Issue (2022)

Voyager Rollator (Compass Health) – Wheel Spoke Crack (2022)

Sensititre Gram Negative Plate (Remel) – MIC Measurement Issue (2022)

Flowflex COVID-19 Antigen Test (Acon) – Inaccurate Results (2022)

Baxter DP MiniCap Transfer Set (Baxter) – Cleaning Product Damage (2022)

Baxter MiniCap Transfer Set (Baxter) – Cleaning Product Damage (2022)

Baxter CAPD Transfer Set (Baxter) – Cleaning Product Damage (2022)

NavitrackER Knee Kit (Zimmer) – Sterilization Concern (2022)

Ingenia 1.5T (Philips) – Magnetic Wheel Risk (2022)

FLEXCERA SMILE (Envisiontec) – Mislabeled Manufacturing (2022)

Ingenia Elition X (Philips) – Magnetic Wheel Risk (2022)

Ingenia Ambition X (Philips) – Magnetic Wheel Risk (2022)

FLEXCERA BASE (Envisiontec) – Mislabeled Manufacturing (2022)

BD Vacutainer Luer Lok Device (Becton Dickinson) – Specimen Contamination (2022)