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ARCHITECT Anti-HCV Reagent Kit (Abbott) – False Elevated Results (2024)

Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).

Low

FDAMar 4, 2024Nationwide• Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany

NEOMED Pharmacy Syringes (Avanos) – Expiration Date Omission (2024)

The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.

Low

FDAMar 4, 2024Nationwide

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ARCHITECT Anti-HCV Reagent Kit (Abbott) – False Elevated Results (2024)

NEOMED Pharmacy Syringes (Avanos) – Expiration Date Omission (2024)

Mojo Non Vented Full Face Mask (SleepNet) – Magnet Warning Update (2024)

Trocar Needle (Cook) – Packaging Seal Strength Issue (2024)

Entuit Suture Anchor Set (Cook) – Packaging Seal Strength Issue (2024)

Peel-Away Introducer (Cook) – Packaging Seal Strength Issue (2024)

Centurion OB Instrument Tray (Medline) – Needle Guide Ring Detachment (2024)

Dilator Coons Taper (Cook) – Packaging Seal Strength Issue (2024)

Mojo Full Face with Headgear (SleepNet) – Magnet Warning Update (2024)

Medline Medical Procedure Kits (Medline) – Needle Guide Ring Detachment (2024)

Dilator (Cook) – Packaging Seal Strength Issue (2024)

HeartMate 3 LVAS Implant Kit (Thoratec) – Potential Leak Risk (2024)

HeNe Laser System (Pacific LaserTech) – Key Control Noncompliance (2024)

Yueh Centesis Disposable Catheter Needle (Cook) – Packaging Seal Strength Issue (2024)

Liquid Protein Calibrators (Randox) – Calibration Realignment (2024)

Phantom 2 Nasal Vented Mask (SleepNet) – Magnet Warning Update (2024)

iQ 2 Nasal Vented Mask (SleepNet) – Magnet Warning Update (2024)

HeNe Laser System (Pacific LaserTech) – Key Control Noncompliance (2024)

HeNe Laser System (Pacific LaserTech) – Key Control Noncompliance (2024)

Triangle Tip Electrosurgical Knives (Olympus) – Breakage Warning (2024)