Z-1825-2013Class II

Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code...

Name: Z-1825-2013 Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code...
Creator: Steritec Products Mfc. Co., Inc.
Published: 2013-06-10
License: https://open.fda.gov/license/

Steritec Products Mfg. Co., Inc. / initiated 2013-06-10 / Terminated / root cause: manufacturing process

FDA source

Steritec Products Mfc. Co., Inc. began a recall of 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... on 2013-06-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1825-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-10
Posted: 2013-07-29
Terminated: 2013-12-19
Recalling firm: Steritec Products Mfg. Co., Inc.
Product: 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 Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.
Product code: FRC Indicator, Biological Sterilization Process
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, SteriTec, sent all customers recall notifications via e-mail. The e-mail included a .pdf file of the recall notification letter entitled "URGENT: MEDICAL DEVICE RECALL" dated June 11, 2013. The letter described the product, problem and actions to be taken. The letter also informed customers of MesaLabs, "URGENT: MEDICAL DEVICE RECALL" letter dated June 7, 2013 to its customers. The customers were instructed to notify SteriTec products of receipt of this notification via email at: [email protected] or fax to: 303-660-4213 Attn: Director Regulatory Affairs; examine the lot number printed on the packaging components; place affected items in hold and do not sell or distribute these lots; record inventory of all items remaining in your warehouse and all items that have been distributed; advise SteriTec of the status of all inventory you received used or unused, if you have distributed the affected product to other locations within your healthcare system, notify them immediately of this recall, ask them to provide inventory status and proceed with destruction or return via instructions provided in letter-If you have shipping questions, please contact SteriTec directly at 303-660-4201, or email us at: [email protected], and also provide this notice to anyone in your facility that needs to be informed. Should you have any questions or concerns, please do not hesitate to contact Director of Regulatory Affairs and Quality Assurance or our offices at 303-660-4201. SteriTec's hours of operation are 7:30am Mountain Standard Time (MST) through 5:00pm MST.
Quantity in commerce: 10,170 units
Distribution: Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
Product codes and lots: Affected Biological Indicator Lot No.:121101-447 and 121101-444

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1825-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1822-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1823-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1824-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1825-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1826-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1827-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1828-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29
Z-1829-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-29

Product code FRC

K111150Class IISteritec Smart-Read Biological Test Pack with Instant Readout IntegratorSteritec Products Mfg Co, Inc. / cleared 2011-07-08

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)