Steritec Products Mfc. Co., Inc.: Medical Device Recall in 2013 - (Recall #: Z-1825-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 10, 2013

Date Posted: August 7, 2013

Recall Number: Z-1825-2013

Event ID: 65473

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.

Status: Terminated

Product Quantity: 10,170 units

Code Information:

Affected Biological Indicator Lot No.:121101-447 and 121101-444

Distribution Pattern:

Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated