Getinge AccuFast Biological Indicators Recalled for Potential False Negative Results
Getinge USA is recalling AccuFast Biological Indicators, Lot SR-430, because exposure to certain conditions may cause false negative results during steam sterilization testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (false negative sterilization results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Getinge USA, Inc. is recalling Getinge Assure AccuFast Biological Indicators, Catalog Numbers 61301606636 (50 Pack) and 61301606637 (100 Pack), specifically Lot SR-430 with an expiration date of 02/06/2014. The affected units were distributed in the USA and Canada.
The recall was initiated because the biological indicators in this lot may have been exposed to conditions that affect their viability. This exposure could result in a false negative (or pass) reading when the indicators are exposed to sub-lethal sterilization parameters. These indicators are designed for biological testing of steam sterilization cycles at 121°C, 132°C, 134°C, and 135°C.
Healthcare facilities and users of these products should stop using the affected Lot SR-430 immediately and contact Getinge USA, Inc. for further instructions on how to return or dispose of the product. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 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 biol
- Manufacturer
- Getinge USA Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LOT SR-430 (Expiration 02/06/2014)
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Getinge USA Inc
See all →- ModerateGetinge 9100-Series Washer Disinfectors Recalled for Ground Fault Breaker Error
FDA (Devices) · 2012-08-01
Same hazard · false negative
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighHologic Aptima HPV assay may produce invalid or false negative results
FDA (Devices) · 2026-03-25
- HighHeparin antibody test kits recalled over a defect producing negative results
FDA (Drugs) · 2026-01-21