26 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; . (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code LBR·November 10, 2009
Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R2. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CIC·November 10, 2009
Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R1. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R1. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CIC·November 10, 2009
Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC902-576 and HC902-1000. Calcium Reagent Set for repackaging, Catalog # HC902-SAM-911. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CIC·November 10, 2009
Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code KNK·December 1, 2009
Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code KNK·December 1, 2009
Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CIG·February 2, 2009
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240, and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code LBR·January 29, 2009
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240 and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code LBR·January 29, 2009
Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath Model Number: TSGP15D
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model Number: TSGP20
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath Model Number: TSGP2S
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model Number: TSGP28
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model Number: TSGP05
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code FMZ·January 8, 2013
Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C7539-150, C7539-625, C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539-R1-120, 8-C7539-R1-500, 8-C7539-R1-1000, 7-C7539-R1-120, 7-C7539-R1-1000, and 7-C7539-R1-500. For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CGX·December 1, 2009