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Dimension Vista TBIL Reagent (Siemens) – Testing Limitation (2024)

During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.

Moderate

FDAJul 30, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

DR 800 X-ray System (Agfa) – Front Lever Chain Failure (2024)

Potential for the front lever chain of the DR 800 table to fail.

Moderate

FDAJul 29, 2024Nationwide• Agfa N.V. Septestraat 27 Mortsel Belgium

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Dimension Vista TBIL Reagent (Siemens) – Testing Limitation (2024)

DR 800 X-ray System (Agfa) – Front Lever Chain Failure (2024)

ADVIA Chemistry UCFP (Siemens) – Quality Control Bias (2024)

Atellica CH UCFP (Siemens) – Quality Control Bias (2024)

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

Arrow Arterial Kits and Trays as follows: (1) Arrow Arte... (ARROW INTERNATIONAL Inc.) – reports have been received regarding ... (2024)

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

BiomarC EX Fiducial Marker System, Catalog Number 040165 (Carbon Medical Technologies, Inc.) – this recall has been initiated due to... (2024)

ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use ... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (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 iBur 3.0mm Diamond Match Head, Distal Bend - inte... (Stryker Corporation) – potential for the product to exhibit ... (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)

Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - in... (Stryker Corporation) – potential for the product to exhibit ... (2024)