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LetsGetChecked Blood Sample Kit (LetsGetChecked) – Mislabeled Samples (2022)

Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sample collection kits that were assigned to another user resulting in a mismatch of user identification. The impact to users is that they may return the sample and obtain potential incorrect Hepatitis C Virus (HCV) results and/or the sample may be rejected due to mismatched demographics resulting in delayed testing and/or treatment.

FDAMar 16, 2022Nationwide• LetsGetChecked Inc.

Enalapril Maleate Tablets (Golden State) – CGMP Deviations (2022)

CGMP Deviations

Class IIModerate

FDAMar 16, 2022Nationwide

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LetsGetChecked Blood Sample Kit (LetsGetChecked) – Mislabeled Samples (2022)

Enalapril Maleate Tablets (Golden State) – CGMP Deviations (2022)

Enalapril Maleate Tablets (Golden State) – CGMP Deviations (2022)

Enalapril Maleate Tablets (Golden State) – CGMP Deviations (2022)

Enalapril Maleate Tablets (Golden State) – CGMP Deviations (2022)

ZEISS miLOOP Lens Device (Carl Zeiss) – High Friction Risk (2022)

PrisMax System (Baxter Healthcare) – Software Anomaly (2022)

PrisMax System (Baxter Healthcare) – Software Anomaly (2022)

Cub 2 Bed Canopy (Sensory Medical) – Warning Update (2022)

ATLAS Stim Headbox (Neuralynx) – Device Exemption Problem (2022)

Virus Counter Platform (Sartorius) – Non-Medical Device (2022)

Abbott Priority Pack (Abbott Vascular) – Connection Leak Risk (2022)

INDEFLATOR Plus 30 (Abbott Vascular) – Connection Leak Risk (2022)

Abbott Priority Pack (Abbott Vascular) – Connection Leak Risk (2022)

20/30 INDEFLATOR (Abbott Vascular) – Connection Leak Risk (2022)

Plus 30 Priority Pack (Abbott Vascular) – Connection Leak Risk (2022)

Gallant VR Defibrillator (St. Jude Medical) – Bluetooth Malfunction (2022)

Merlin PCS Programmer (St. Jude Medical) – Software Anomaly (2022)

Merlin 2 PCS Programmer (St. Jude Medical) – Software Anomaly (2022)

Gallant DR Defibrillator (St. Jude Medical) – Bluetooth Malfunction (2022)