Getinge Assure Accufast Biological Indicators recall
Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge…
Why was Getinge Assure Accufast Biological Indicators recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
LOT SR-430 (Expiration 02/06/2014)
- Product
- Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge…
- Recalling firm
- Getinge USA Inc
- Quantity
- Catalog # 61301606636: 78 Packs (3900 BIs); Catalog # 61301606637: 43 Packs (4300 BIs)
- Distribution
- Worldwide Distribution - USA and the country of Canada.
- Recall date
- August 28, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)