23 results
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14ms
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Sources: EU EUDAMED, US FDA
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code OYT·April 23, 2012
VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle). The responsible firm on the kit label is bioMerieux sa, 69280 Marcy l''Etoile France. The responsible firm on the insert is bioMerieux, Inc., Durham, NC.
FDA Recall
Terminated
·Biomerieux, Inc.·Product code LSR·October 28, 2003
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code GDJ·July 2, 2013
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GJS·November 21, 2014
Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS
FDA Recall
Terminated
·Ossur Grjothals 5 Reykjavik Ireland·Product code LYT·September 26, 2008
Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS
FDA Recall
Terminated
·Ossur Grjothals 5 Reykjavik Ireland·Product code LYT·September 26, 2008
Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S
FDA Recall
Terminated
·Ossur Grjothals 5 Reykjavik Ireland·Product code LYT·September 26, 2008
Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skull Pin 2-1/4in CT Sterl 1PK; 516DS/ Skull Pin 3in CT Sterl 1PK; 517CS/ Skull Pin 2-1/4in CT Sterl 4PK; 517DS/ Skull Pin 3in CT Sterl 4 PK; 522CS/ Skull Pin 2-1/4in CT Sterl 6PK; 522C/ SKULL PIN 2-1/4 CT 6 PK
FDA Recall
Terminated
·Ossur Americas·Product code LYT·June 21, 2018
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
FDA Recall
Terminated
·INNOKAS MEDICAL OY TARJUSOJANTIE 12 KEMPELE Finland·Product code MWI·December 3, 2014
KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Recall
Terminated
·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020
Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Recall
Terminated
·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
FDA Recall
Terminated
·INNOKAS MEDICAL OY TARJUSOJANTIE 12 KEMPELE Finland·Product code MWI·July 27, 2016
CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
FDA Recall
Terminated
·Innokas Medical Oy Vihikari 10 Kempele Finland·Product code MWI·October 22, 2015
Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Recall
Terminated
·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020
Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Recall
Terminated
·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020
Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code KHO·January 9, 2012
NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code NQL·November 2, 2017
Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JQP·March 7, 2017
Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code KHO·January 5, 2017
Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code KHO·January 5, 2017