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ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use ... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

Moderate

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Progesterone Injection (Eugia US LLC) – Glass Particle Risk (2024)

Presence of Particulate Matter: Complaint received of a glass particle in the vial.

Class IIModerate

FDAJul 26, 2024Nationwide

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ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use ... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Progesterone Injection (Eugia US LLC) – Glass Particle Risk (2024)

CustomEyes Procedure Packs (Beaver Visitec) – Syringe Recall (2024)

Atellica IM CA 19-9 (Siemens) – Test Result Bias (2024)

Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic ... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use i... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)

Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/... (Intrinsic Therapeutics, Inc.) – at least two units have been found to... (2024)

Vivo 45 LS, pressure and volume ventilator capable of del... (Breas Medical, Inc.) – there is a potential for short term (... (2024)

NEUROSIGN Disposable Stimulating Dissector, REF 5888-00 (Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands) – product has have presence of brown di... (2024)

Stryker TMJ Unilateral Implant, REF: GHG010, consisting ... (TMJ Solutions Inc) – patient-fitted temporomandibular (tmj... (2024)

regard Clinical Packaging Solutions, HT00376I - SPECIAL P... (ROi CPS LLC) – medical convenience kits were distrib... (2024)

FreeStyle Libre 3 Sensors, REF: 72081-01, component of th... (Abbott Diabetes Care, Inc.) – laceration hazard (2024)

McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 10... (Cypress Medical Products LLC) – affected syringes lack fda clearance (2024)

(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 1... (Cardinal Health 200, LLC) – the firm received reports of breakage... (2024)

CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number... (Schiller, Ag Altgasse 68 Baar Switzerland) – potential for high-frequency signal a... (2024)

Coconutmilk Chocolate Almond Crunch (Full Circle) – Undeclared Cashews (2024)

Sodium Chloride Injection (B. Braun) – Particulate Matter (2024)

Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope ... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MI... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)