34 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·October 16, 2013
Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS.
FDA Recall
Terminated
·Remel, Inc.·Product code JSI·February 21, 2007
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·November 21, 2018
Dental Explorer Single End #7, Mfr. Part Code/Product Code 100-7409. Distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN 100-7409 Explorer - Single End #7 SE. +H65810074090C. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling).
FDA Recall
Terminated
·Hu-Friedy Mfg Co, Inc.·Product code EKB·January 7, 2005
Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
FDA Enforcement
Class II
·Terminated·Haemonetics Corporation·February 6, 2019
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
Clearview iFOB, Clearview - Sample Kit (5 Test)Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8112KCV (5 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
FDA Recall
Terminated
·Alere North Americal
30 S Keller Rd Ste 100
Suite 100
Orlando FL 32810-6297·Product code KHE·March 21, 2011
Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8111KCV (30 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
FDA Recall
Terminated
·Alere North Americal
30 S Keller Rd Ste 100
Suite 100
Orlando FL 32810-6297·Product code KHE·March 21, 2011
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
FDA Recall
Terminated
·Enterix, Inc.·Product code KHE·October 8, 2020
Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8115KCV (25 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
FDA Recall
Terminated
·Alere North Americal
30 S Keller Rd Ste 100
Suite 100
Orlando FL 32810-6297·Product code KHE·March 21, 2011
Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine test strips for various urine analytes.: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood
FDA Recall
Terminated
·Roche Diagnostics Corporation·Product code KHE·September 24, 2018
Clearview iFOB, Clearview - Clearview iFOB Specimen Collection (accessory) Product Part Number: 8116KCV Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
FDA Recall
Terminated
·Alere North Americal
30 S Keller Rd Ste 100
Suite 100
Orlando FL 32810-6297·Product code KHE·March 21, 2011
Clearview iFOB, Clearview - Clearview iFOB Return Mailer(accessory) Product Part Number: 8117KCV Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
FDA Recall
Terminated
·Alere North Americal
30 S Keller Rd Ste 100
Suite 100
Orlando FL 32810-6297·Product code KHE·March 21, 2011
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code KHE·July 17, 2013
Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flushable Collection Tissues; Mailing Pouches (for returning completed Test Cares); Hemoccult II SENSA elite Product Instructions; Beckman Coulter, Inc.; 250 S. Kraemer Blvd.; Brea, CA 92821 The Hemoccult II SENSA elite test is a rapid, convenient and qualitative method for detecting fecal occult blood which may be indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific diseases. The Hemoccult II SENSA elite test is recommended for professional use as a diagnostic aid during routine physical examinations, for hospital patients to monitor for gastrointestinal bleeding in patients with iron deficiency anemia or recuperating from surgery, peptic ulcer, ulcerative colitis and other conditions, and in screening programs for colorectal cancer when the Patient Instructions are closely followed. Serial fecal specimen analysis is recommended when screening symptomatic patients. The Hemoccult II SENSA elite test and other unmodified guaiac tests are not recommended for use with gastric specimens.
FDA Recall
Terminated
·Product code KHE·July 16, 2013
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
FDA Recall
Terminated
·Polymedco, Inc·Product code KHE·February 12, 2013
Stryker Trio Mobile Surgery Platform; Model 1033.
FDA Recall
Terminated
·Stryker Medical Div. of Stryker Corporation·Product code FSE·May 15, 2006
Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (25 Test) Immunochemical Fecal Occult Blood Cassette Test Product Part Number: 8114KCV (25 Test Kit ), Intended Use: Immunochemical device intended for the qualitative detection if fecal occult blood in human feces by laboratories or physician offices
FDA Recall
Terminated
·Alere North Americal
30 S Keller Rd Ste 100
Suite 100
Orlando FL 32810-6297·Product code KHE·March 21, 2011
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
FDA Recall
Terminated
·Polymedco, Inc·Product code KHE·February 12, 2013
McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178CK30
FDA Recall
Terminated
·Cypress Medical Products LLC·Product code KHE·February 27, 2019