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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65866

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 02, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Getinge USA Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1994-2013
Recall number
Z-1994-2013
Initiated
August 02, 2013
Classification
Class II
Status
Terminated
Recalling firm
Getinge USA Inc
Quantity
Catalog # 61301606636: 78 Packs (3900 BIs); Catalog # 61301606637: 43 Packs (4300 BIs)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

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.

Code information

LOT SR-430 (Expiration 02/06/2014)

Distribution pattern

Worldwide Distribution - USA and the country of Canada.