950 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BD VERITOR PLUS ANALYZER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JJQ·August 25, 2021
BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·January 13, 2021
Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.
FDA Recall
Terminated
·Hamilton Co·Product code JJE·September 26, 2011
TDXFLX SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJQ·January 11, 2012
TDX FPIA ANALYZER
FDA Adverse Event
Injury
·ABBOTT MANUFACTURING, INC.·Product code JJQ·February 2, 2009
IMMULITE 2500
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJQ·January 26, 2009
IMX ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJQ·March 17, 2009
TDXFLX SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJQ·February 9, 2009
TDXFLX SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJQ·April 14, 2014
IMMULITE 2000 XPI
FDA Adverse Event
Malfunction
·SIEMENS HEALTCHCARE DIAGNOSTICS INC·Product code JJQ·May 23, 2014
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJQ·May 29, 2014
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJQ·June 13, 2014
IMMULITE 2000 XPI
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJQ·May 27, 2014
IMMULITE 2000 XPI
FDA Adverse Event
Malfunction
·SIEMENS HEALTCHCARE DIAGNOSTICS INC·Product code JJQ·May 13, 2014
IMMULITE 1000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJQ·April 2, 2014
IMMULITE 1000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJQ·April 10, 2014
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTCHCARE DIAGNOSTICS INC·Product code JJQ·April 21, 2014
UBIT-IR300 INFRARED SPECTROPHOTOMETER
FDA Adverse Event
Malfunction
·OTSUKA ELECTRONICS CO., LTD.·Product code JJQ·March 12, 2010
IMMULITE 2500
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJQ·March 2, 2010
IMMULITE 2500
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJQ·May 27, 2010