Reported Aug 7, 2013 · Terminated
Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638…
Steritec Products Mfc. Co., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Steritec Products Mfc. Co., Inc. · 74 Inverness Drive East · Englewood, CO · 80112-5114
Is this the product you have?
- Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test
- Pack with Instant Readout Integratoris designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers
- Lot codes and dates
- Affected Biological Indicator Lot No.:121101-447 and 121101-444
- Amount recalled
- 10,170 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Steritec Products Mfc. Co., Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.