218 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Pointe Scientific, Inc. Iron Buffer Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-BUF-1000, 7-I7504-BUF-120, 7-I7504-BUF-75, 8-I7504-BUF-500 and 3-I7504-BUF. Clinical chemistry reagent for the quantitative determination of iron in serum.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code JIY·November 16, 2009
Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-COL-15, 7-I7504-COL-5, 7-I7504-COL-60, 8-I7504-COL-15, 8-I7504-COL-60 and 3-I7504-COL. Clinical chemistry reagent for the quantitative determination of iron in serum.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code JIY·November 16, 2009
Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: HI704-300, HI904-1200, HI904-498, HI904-600, HI904-SAM-911, HI904-SAM-917 and 12-HI904-144. Clinical chemistry reagent for the quantitative determination of iron in serum.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code JIY·November 16, 2009
Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7505-120, I7505-500. Clinical chemistry reagent for the quantitative determination of iron in serum.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code JIY·November 16, 2009
Dimension Vista IRON Flex reagent cartridges
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIY·August 25, 2016
Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of iron in serum and plasma.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JIY·June 11, 2008
Dimension IRON Flex reagent cartridges
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIY·August 25, 2016
Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIY·October 8, 2012
Pointe Scientific Iron Reagent (R2), for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: 8HI904-R2-100.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code JIY·November 16, 2009
VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924547 VITROS Fe Slides quantitatively measure iron (Fe) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JIY·June 12, 2013
Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron and iron binding capacity, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7504-60, I7504-400, I7504-SAM, 10-I7504-60. Clinical chemistry reagent for the quantitative determination of iron in serum.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code JIY·November 16, 2009
Pointe Scientific Iron (Ferrozine) R2 Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: HI404-R2. Clinical chemistry reagent for the quantitative determination of iron in serum.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code JIY·November 16, 2009
Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: HI404-R1. Clinical chemistry reagent for the quantitative determination of iron in serum.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code JIY·November 16, 2009
Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Recall
Terminated
·Sterling Diagnostics, Inc.·Product code JIY·July 20, 2016
Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale)
FDA Recall
Terminated
·Arjo, Inc.·Product code FSA·April 30, 2004
Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
FDA Recall
Terminated
·Tornier, Inc·Product code HSB·June 25, 2015
Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Tornier, Inc·August 5, 2015
Minerva-Combi Patient Lift, model ML-30; this lift comes with interchangable passive and active lifting units; Manufactured by Medibo-Technics, Hasseltsebaan 24, 3940 Hechtel-Eksel, Belgium and distributed by MasterCare Patient Equipment, Inc., Hwy 61 West Industrial Park, Columbus, NE 68601
FDA Recall
Terminated
·Medibo N.V. Heikant 5 Hanmont, Achel Belgium·Product code FSA·August 4, 2004
@ Home Strep Test Rapid Strep Test Product Usage: For in-vitro diagnostic use - detection of Strep.
FDA Recall
Terminated
·Jay Bird Investments Inc·Product code GTY·July 6, 2011
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code LXH·October 15, 2014