Dna-probe, Reagents, Streptococcal
Microbiology · 21 CFR 866.3740
Recent MDR events
4 adverse event reports on file
- ACCUPROBE GROUP B STREP TESTMar 14, 2014Gen-probe Incorporated2024800-2014-00002
- ACCUPROBE GROUP B STREPTOCOCCUS CULTURE ID KITJan 26, 2012InjuryGen-probe Incorporated2024800-2012-00001
- ACCUPROBE GROUP B STREPTOCOCCUS CULTURE ID KITAug 13, 2010InjuryGen-probe, Inc.2024800-2010-00003
- ACCUPROBE GROUP B STREPTOCOCCUS CULTURE ID KITApr 6, 2010DeathGen-probe Incorporated2024800-2010-00001
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Gen-Probe IncTerminatedMar 10, 2011
Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.
This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results.
Z-1436-2011 · View FDA record ↗ - Gen-Probe IncTerminatedDec 19, 2007
Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches
Z-0145-2008 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
4 clearances for this product code
- Chugai Pharmaceuticals Co., Ltd.Sep 24, 1998
K974572 · GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820
- Gen-Probe, Inc.Mar 11, 1994
K924715 · GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST
- Gen-Probe, Inc.Apr 2, 1992
K915852 · ACCUPACE GROUP A STREPTOCOCCUS ID TEST
- Gen-Probe, Inc.Nov 13, 1990
K904268 · ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.