Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 28, 2013
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
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 st…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Getinge USA Inc recalled Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 6… - a moderate-severity action.
Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 6… was recalled by Getinge USA Inc in August 28, 2013. Reason: AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This co…. Check the official notice for the remedy. Verify recall #Z-1994-2013 with the FDA Devices before acting.
The recall
Getinge USA Inc issued this moderate-severity FDA Devices recall-AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This co….
- Moderate
- severity level
- Class II
- classification
- August 28, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1994-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1994-2013) was formally reported on August 28, 2013, with the manufacturer initiating the action on August 2, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Getinge USA Inc is listed as the recalling firm, operating out of Rochester, NY. Federal records list the affected scope as Catalog # 61301606636: 78 Packs (3900 BIs); Catalog # 61301606637: 43 Packs (4300 BIs).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA and the country of Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Catalog # 61301606636: 78 Packs (3900 BIs); Catalog # 61301606637: 43 Packs (4300 BIs)
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1994-2013 |
| Date reported | August 28, 2013 |
| Date initiated | August 2, 2013 |
| Recalling firm | Getinge USA Inc |
| Firm location | Rochester, NY |
| Affected scope | Catalog # 61301606636: 78 Packs (3900 BIs); Catalog # 61301606637: 43 Packs (4300 BIs) |
| Distribution | Worldwide Distribution - USA and the country of Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1994-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Getinge USA Inc. Units affected: Catalog # 61301606636: 78 Packs (3900 BIs); Catalog # 61301606637: 43 Packs (4300 BIs).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2013. Severity: Moderate. Recall number: Z-1994-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA and the country of Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1994-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 28, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.