Getinge Assure Accufast Biological Indicators — Class II medical device recall Z-1994-2013
Terminated recall by Getinge USA Inc, reported 2013-08-28. AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This cou
| Recall number | Z-1994-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge USA Inc, Rochester, NY, United States |
| Recall initiated | 2013-08-02 |
| Classified | 2013-08-21 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2017-02-23 |
| Countries outside the US | CA |
| Lot numbers | R-430 |
| Model numbers | 61301606636 |
| Expiration dates | 2014-02-06 |
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 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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1994-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.