Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0318-2013·Announced 2012-11-28

BioMerieux BacT/ALERT Control Module Recalled for Software Mislabeling

BioMerieux is recalling BacT/ALERT Control Modules because a software issue may cause patient information to be mislabeled on culture specimen bottles.

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, and the hazard involves a software error leading to mislabeling of patient information, which fits the criteria for moderate severity involving labeling errors without reported injuries.

Plain-English summary

BioMerieux Inc is recalling two BacT/ALERT Control Modules, catalog number 210148, identified by B.40 firmware. These industrial instruments are used to isolate and recover specimens from patients with suspected bloodstream infections.

The recall is due to a software miscommunication that may cause the product to mislabel patient information on culture specimen bottles. The affected units were distributed worldwide, including in the United States and numerous international locations.

Healthcare facilities should contact BioMerieux Inc for further instructions regarding the recall and replacement of the affected modules.

The recalled product

Product: bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream…
Manufacturer: Biomerieux Inc
Category: Medical Device — Laboratory Instrument
Hazard: mis-labeling
Affected units: 2

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)

Identified by B.40 firmware

Distribution

Distributed in 19 states:

Part of a larger recall action

This product is one of 31 recalled by Biomerieux Inc 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 31 products in this recall →

Same manufacturer · Biomerieux Inc

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