FDAFDA · Food and drugs·Recall number Z-1994-2013
Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. The AccuFast BI is a self-contained biological indicator containing Geobacillus stearothermophilus inoculated on a paper carrier and placed in a plastic vial with a small glass ampule containing sterile culture medium. After activation, the plastic vial serves as a culture tube. The chemical indicator on the label changes from blue to black when exposed to steam, distinguishing exposed from unexposed units. This indicator does not indicate adequate sterilization.
Published August 28, 2013 · Recall initiated: August 2, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Getinge USA Inc
- Distributor
- Worldwide Distribution - USA and the country of Canada.
- Lot
- LOT SR-430 (Expiration 02/06/2014)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.