Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1867-2013·Announced 2013-08-07

Mesa EZtest Biological Indicator Monitor Recall for Readout Time Issues

Mesa Laboratories is recalling EZtest biological indicator monitoring systems because the readout time does not match label claims.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a discrepancy between the readout time and label claims, which is a functional defect rather than a direct physical injury or contamination risk, fitting the criteria for moderate severity.

Plain-English summary

Mesa Laboratories, Inc. is recalling the Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. This product is intended for use in determining the efficacy of steam sterilization processes.

The recall was initiated because Mesa determined that the readout time is not in specification with the label claims. The affected products include 865/25 ct boxes, 414/100 ct boxes, and 307/500 ct boxes. Specific lots affected are S-444, S-445, and S-447, with manufacture dates ranging from January 21, 2013, to March 18, 2013.

The products were distributed worldwide, including in the United States and various international markets. Users of these biological indicators should stop using the affected lots and contact Mesa Laboratories for further instructions.

The recalled product

Product: Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Manufacturer: Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Category: Medical Device — Sterilization Monitoring
Hazard: mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Lot No S-444 Manufacture Date 2013 January 21 Expiration Date 2015 January 21
Lot No S-445 Manufacture Date 2013 February 15 Expiration Date 2015 February 15
Lot No S-447 Manufacture Date 2013 March 18 Expiration Date 2015 March 18.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Mesa Laboratories, Inc., Bozeman Manufacturing Facility under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Mesa Laboratories, Inc., Bozeman Manufacturing Facility

See all →

Moderate
Mesa Smart-Read EZTEST Biological Indicator Monitor Recall for Labeling Error
FDA (Devices) · 2013-08-07

Same hazard · mis labeling