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Roche cobas IT 1000 Product Usage: Intended Use: An e... (Roche Diagnostics Operations, Inc.) – potential that test results would be ... (2014)

Potential that test results would be assigned to the wrong Patient ID if cobas IT 1000 receives an ADT ADMIT, TRANSFER or MERGE event message that contains a genuine Patient ID (e.g. 999999), which is the same as what has been configured as the Generic Patient ID (999999 by default).

Class IIModerate

FDAJul 31, 2014Nationwide• Roche Diagnostics Operations, Inc.

CLAW II 2 Hole Plate (Wright Medical) – Incorrect Raw Material (2014)

Plates manufactured from an incorrect raw material.

Class IIModerate

FDA

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Roche cobas IT 1000 Product Usage: Intended Use: An e... (Roche Diagnostics Operations, Inc.) – potential that test results would be ... (2014)

CLAW II 2 Hole Plate (Wright Medical) – Incorrect Raw Material (2014)

CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 4024... (Wright Medical Technology, Inc.) – plates manufactured from an incorrect... (2014)

CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm,... (Wright Medical Technology, Inc.) – plates manufactured from an incorrect... (2014)

Goya Whole Green Peas (Tradewind Foods) – Can Seam Defect (2014)

Zimmer Gender Solution Patello-Femoral Joint (PFJ) System... (Zimmer, Inc.) – metal contamination (2014)

Goya Pink Beans (Tradewind Foods) – Can Seam Defect (2014)

Goya Red Kidney Beans (Tradewind Foods) – Can Seam Defect (2014)

Goya Black Bean Soup (Tradewind Foods) – Can Seam Defect (2014)

Goya Pinto Beans (Tradewind Foods) – Can Seam Defect (2014)

Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile.... (Zimmer, Inc.) – persona distal valgus alignment guide... (2014)

CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm,... (Wright Medical Technology, Inc.) – plates manufactured from an incorrect... (2014)

CLAW 3.5mm Plate (Wright Medical) – Incorrect Raw Material (2014)

Goya Pinto Beans (Tradewind Foods) – Can Seam Defect (2014)

Integra Container Lid (Integra York) – Uncertified Product (2014)

Goya Black Beans (Tradewind Foods) – Can Seam Defect (2014)

CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm,... (Wright Medical Technology, Inc.) – plates manufactured from an incorrect... (2014)

CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 4024... (Wright Medical Technology, Inc.) – plates manufactured from an incorrect... (2014)

Alprazolam Tablets (Mckesson) – metal particulates (2014)

Goya Small Red Beans (Tradewind Foods) – Can Seam Defect (2014)