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Alinity i 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

X-Guide Handpiece Adaptor Sleeve (X-NAV) – Manufacturing Geometry Defect (2024)

The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.

Low

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

X-Guide Handpiece Adaptor Sleeve (X-NAV) – Manufacturing Geometry Defect (2024)

EZ2 Connect MDx-IVD (Qiagen) – Heater Cable Failure (2024)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Mojo 2 Full Face Vented Mask (SleepNet) – Magnet Warning Update (2024)

Chiba Biopsy Needle (Cook) – Packaging Seal Strength Issue (2024)

VITROS Anti HBs Calibrators (Ortho-Clinical) – Signal Reduction Risk (2024)