Z-1994-2013Class II

Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100...

Name: Z-1994-2013 Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100...
Creator: Getinge USA Inc
Published: 2013-08-02
License: https://open.fda.gov/license/

Getinge USA, Inc. / initiated 2013-08-02 / Terminated / root cause: sterility

FDA source

Getinge USA Inc began a recall of Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc... on 2013-08-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1994-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-02
Posted: 2013-08-21
Terminated: 2017-02-23
Recalling firm: Getinge USA, Inc.
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 121C, 132C, 134C and 135C 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.
Product code: FRC Indicator, Biological Sterilization Process
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.
Root cause tag: sterility
FDA root cause: Other
Action: GETINGE sent an DEVICE CORRECTION NOTICE letter dated July 31, 2013, and response forms were sent to customers on August 2, 2013, via Certified Mail Return Receipt Requested. The letters instruct customers to immediately discontinue use, quarantine, and destroy the affected lot. In addition, they instruct customers to: Check the appropriate box and record the quantity of affected unused product on the enclosed Correction Response Form OR If if they do not have any lots of affected unused inventory check the box indicating such. Destroy the unused product in accordance with your institution's policy and instructions for use. Record the method of destruction on the Correction Response Form. Be sure to include the Facility Name, Address, Contact Name and Phone Number. Sign, date and e-mail the form back to [email protected] within 10 days or sooner of receiving this notice. Credit will be issued upon receipt of the Correction Response Form. Replacement product of unaffected lots is currently available. The warehouse shipping the affected lot is no longer being used (due to business decision, not as result of this recall). The current warehouse is maintaining the product in a controlled temperature segregated room away from any potential sterilants. If you have any questions regarding this notification please call 1-800-475-1400 ext. 5026
Quantity in commerce: Catalog # 61301606636: 78 Packs (3900 BIs); Catalog # 61301606637: 43 Packs (4300 BIs)
Distribution: Worldwide Distribution - USA and the country of Canada.
Product codes and lots: LOT SR-430 (Expiration 02/06/2014)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1994-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1994-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-21

Product code FRC

K093794Class IISmart-Read Eztest-Steam Scbi and Test PackSgm Biotech, Inc. / cleared 2010-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)