MXBClass I

Test, Vaginal, Bacterial Sialidase

Microbiology · 21 CFR 866.2660

MDR events2All time

Recalls1All time

Registered firms6Currently listed

510(k) clearances2All time

Recent MDR events

2 adverse event reports on file

Event type breakdown

Malfunction1

Other1

Most-reported manufacturers

Unspecified1 Sekisui Diagnostics1

Recalls

1 recall events for this product code

Mckesson Medical-Surgical Inc. Corporate Office
Open, ClassifiedMar 19, 2024
Sekisui Diagnostics Control Kit OSOM BVBLUE Bacterial Vaginosis
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes .
Z-1311-2024 · View FDA record ↗

Registered firms

6 firms currently registered for this product code

510(k) clearances

2 clearances for this product code