106 results
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21ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JNO·September 25, 2017
The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm. FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
FDA Recall
Terminated
·Instrumentarium Dental, PaloDEx Group Oy Nahkelantie 160 Tuusula Finland·Product code EHD·January 14, 2014
AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
FDA Recall
Open, Classified
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JHJ·January 10, 2019
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
FDA Recall
Terminated
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JQP·November 17, 2017
AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
FDA Recall
Open, Classified
·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JHJ·January 10, 2019