QwikCheck Beads Open Vial Shelf Life

April 2, 2019

Background:
QwikCheck™ Beads (Medical Electronic Systems) have an open and a closed vial shelf life. This labeling insures accurate results that could be compromised due to bead evaporation over time which can be related to high ambient laboratory temperature and/or infrequent use of the beads.

Storage conditions:
The stability of the QwikCheck™ Beads control material is highly dependent on maintaining an intact matrix volume. Therefore, storage conditions and timeframes for use after opening are recommended as follows:
1. Each kit contains two known concentrations of QwikCheckTM Beads in two 5 ml aliquots and one 5 ml negative concentration and motility control.
2. Store unopened bead kits @ 15-30°C (60-86°F).
3. After opening for the first time, store @ 15-30°C (60-86°F) for 90 days.
4. NO need to refrigerate the material.
5. The labeled storage expiration date assumes that QwikCheckTM Beads are stored in their original containers and are tightly capped to prevent evaporation.
6. QwikCheckTM beads are stable and show no loss of expected performance characteristics after transport/storage over a period of 72 hours at the temperature range of -20°C to +37°C (-4°F to +99°F).

Compliance Date: Effective March 26, 2019. 
Authority: Marina Friling, Clinical Director
Distribution: ALL QwikCheck Bead users

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