Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 12 — recall Z-1994-2013

U.S. FDA — Device Enforcement · United States · 2013-08-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1994-2013
Date of alert: 2013-08-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Getinge USA Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 61301606636

Reported risk: 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.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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