SLIDEX ROTA KIT 2
Received Feb 5, 1998
Report MW1012955 · MDR key 147761
Device
Generic name
Rotavirus Antigen Detector Kit
Manufacturer
Biomerieux Vitek, Inc.Model number
*Catalog number
*
Lot number
*
Product problems
- Labelling, Instructions for Use or Training Problem
Patient
*
Narrative
Description of Event or Problem
A KIT CALLED SLIDEX ROTA KIT 2, USED FOR DETECTING THE ANTIGEN OF THE GROUP OF VIRUSES CALLED ROTAVIRUS, AND MARKETED BY BIOMERIEUX VITEK, WITH OFFICES AT 595 ANGIUM DRIVE, HAZELWOOD, MO 63042, STATES IN ITS PACKAGE INSERT "DO NOT INTERCHANGE REAGENTS BETWEEN DIFFERENT LOT NUMBERS. HOWEVER, THE KITS CONTAIN THREE VIALS EACH WITH A DIFFERENT LOT NO, AND THE BOX CONTAINS A YET DIFFERENT NUMBER. HOW IS THE CUSTOMER TO KNOW WHETHER THE VIALS WERE ASSEMBLED CORRECTLY BY THE MFR IF THERE ARE NO CLUES AS TO WHICH NUMBERS GO TOGETHER AND WHICH ONES DO NOT MATCH? AT THE VERY LEAST, THE BOX OR THE PACKAGE INSERT SHOULD GIVE A KEY TO THE LOT NUMBERS OF THE VIALS THAT BELONG IN THAT BOX.