FDA Recalls & Safety Alerts - The Conscious Plate

Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients Class II

Reason: Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.

Siemens Healthcare Diagnostics, Inc. 20130425 Terminated

Distributed: Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI.

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HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320 Class II

Reason: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

Instrumentation Laboratory Co. 20131115 Terminated

Distributed: Nationwide Distribution

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HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 Class II

Reason: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

Instrumentation Laboratory Co. 20131115 Terminated

Distributed: Nationwide Distribution

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HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 Class II

Reason: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

Instrumentation Laboratory Co. 20131115 Terminated

Distributed: Nationwide Distribution

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Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma. Class II

Reason: Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received.

Microgenics Corp 20131016 Terminated

Distributed: Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.

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Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms. Class II

Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.