7 results
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39ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.
FDA Enforcement
Class III
·Terminated·Gen-Probe Inc·June 25, 2014
Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
FDA Recall
Terminated
·Gen-Probe Inc·Product code MDK·May 2, 2007
Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.
FDA Recall
Terminated
·Gen-Probe Inc·Product code LQF·December 30, 2008
Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.
FDA Recall
Terminated
·Gen-Probe Inc·Product code MDK·December 30, 2008
Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.
FDA Recall
Terminated
·Gen-Probe Inc·Product code LQF·December 30, 2008
Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,
FDA Recall
Terminated
·Gen Probe Inc·Product code NDZ·June 11, 2004
APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.
FDA Recall
Terminated
·Gen-Probe Inc·Product code OIE·April 17, 2014