162 results
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13ms
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Sources: EU EUDAMED, US FDA
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Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
FDA Enforcement
Class III
·Terminated·Randox Laboratories Ltd.·February 12, 2020
Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.
FDA Enforcement
Class III
·Terminated·Beckman Coulter Inc.·August 29, 2012
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·April 12, 2017
BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code MLA·June 13, 2013
BD AffirM VPIII Microbial Identification Test
FDA Recall
Terminated
·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code MLA·August 27, 2015
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports and OPTION-LOK, 15 drops/mL; a sterile Rx single patient device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160080401, list number 16008-01.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Primary Latex-Free Symbiq Pump Set, piggyback with backcheck valve, 2 prepierced Y-sites, 0.2 micron filter, 104 inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa; product 160880428, list number 16088-28.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-Free Primary Symbiq Pump Set, piggyback with backcheck valve, 2 CLAVE Y-sites, 105 inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160900428, list number 16090-28.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-Free Symbiq Pump Set, convertible pin, 104 inch piggyback with backcheck valve, 2 CLAVE ports, 0.2 micron filter and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160220401, list number 16022-01.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Primary Symbiq Pump Set, piggyback with backcheck valve, 2 prepierced sites, 105 inch, Latex-Free, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. made in Costa Rica; product 160890428, list number 16089-28.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160190401, list number 16019-01.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Primary Symbiq Set, Latex-Free with Polyethylene Lined Tubing, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Ireland, Made in Costa Rica; product 160470701, REF 16047.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Ireland, Made in Costa Rica; product 161010728, REF16101
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 prepierced injection sites, distal microbore tubing and OPTION-LOK, MICRODRIP, non-DEHP, 60 drops/mL; a sterile Rx device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160390428, list number 16039-28.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-Free Symbiq Pump Set, convertible pin, 104.5 inch with Polyethylene-Lined tubing, backcheck valve, 2 CLAVE ports, 0.2 micron filter, and OPTION-LOK, piggyback, 15 drops/mL; a sterile Rx device, Hospira Inc., Lake Forest, IL USA. Made in Costa Rica; product 160130401, list number 16013-01.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Primary Symbiq Set, Latex-Free, Polyethylene-Lined tubing, piggyback with backcheck valve, 2 CLAVE Y-sites, 0.2 micron filter, 104 inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160930428, list number 16093-28.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-Free Symbiq Pump Set, convertible pin, 106 inch, piggyback with backcheck valve, 3 CLAVE ports, and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160210401, list number 16021-01
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-Free Symbiq Pump Set, convertible pin, 106 inch, piggyback with backcheck valve, 3 prepierced injection sites, and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160380428, list number 16038-28.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Primary Symbiq Pump Set, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Ireland, Made in Costa Rica; product 160490728, REF 16049 .
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Ireland, Made in Costa Rica; product 160980728, REF 16098.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009