The Recall Desk
HighFDA (Devices)·Z-2002-2014·Announced 2014-07-16

3M Attest Auto-reader Recalled for Missing Dry Natural Rubber Labeling

3M is recalling Attest Auto-readers because labels failed to disclose dry natural rubber content, posing an allergy risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (allergic reaction) where injury has been reported, but it is not classified as FDA Class I or associated with death/serious injury, fitting the High severity criteria.

Plain-English summary

3M Company - Health Care Business is recalling 3M Attest Auto-readers, model numbers 390, 390G, and 490. These devices are used to incubate biological indicators to determine the results of sterilization cycles. The recall involves 5,343 units distributed worldwide, including the United States, Canada, and various countries in Asia, Europe, South America, and Africa.

The recall was initiated because the labeling on units shipped prior to May 16, 2014, did not include the required statement: "This product contains dry natural rubber." The non-slip pads located at the bottom of the unit contain this material. The omission of this warning is a violation of FDA requirements for medical devices.

One incident of an allergic reaction in a sensitized individual has been reported. Users of these devices should check their model numbers and shipping dates to determine if they are affected. If the device was shipped before May 16, 2014, it may lack the necessary warning label regarding the presence of dry natural rubber.

The recalled product

Product
3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
Manufacturer
3M Company - Health Care Business
Category
Medical Device — Sterilization Equipment
Hazard

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 (1)

  • All serial numbers.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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