35 results
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9ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
FDA Enforcement
Class II
·Terminated·Greiner Bio-One North America, Inc.·October 6, 2021
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
FDA Recall
Terminated
·Greiner Bio-One North America, Inc.·Product code JKA·August 13, 2021
Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.
FDA Recall
Terminated
·Greiner Bio-One North America, Inc.·Product code JKA·August 12, 2011
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·March 21, 2018
BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·December 30, 2015
BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·August 29, 2017
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 13, 0012
diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, manufactured by diaDexus Inc, South San Francisco, CA 94080, Catalog number 90110 Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.
FDA Recall
Terminated
·DiaDexus, Inc·Product code NOE·November 4, 2008
3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-15Y, 1 in x 5YDS., 441 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-336, 3 in x 36 in., 240 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-136, 1 in x 36 in., 800 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-118, 1 in x 18 in., 800 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-12Y, 1 in x 2YDS., 630 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-254, 2 in x 54 in., 400 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Single Use Rolls, Surgical Tape, REF 1530S-1, 1 in x 1-1/2 yd.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·November 17, 2015
INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit) and 50025 (INSURE(R) QUIK FIT(TM) containing Developer Kit and Patient Collection Kits. Product Number 30025 - InSure(R) Quik FIT)TM) Developer Kit (1 Box) . Each box contains: 25 InSure(R) Quik FIT(TM) Test Strips (1 per foil pack), 1 InSure(R) Quik FIT(TM) Conjugate Solution, I InSure(R) Quik FIT(TM) Run Buffer, and 1 InSure(R) Quik FIT(TM) Product Instructions. Product 50025 - InSure(R) Quik FIT(TM) contains 25 Patient Kits & 1 Developer Kit.
FDA Recall
Terminated
·Enterix, Inc.·Product code KHE·October 3, 2008