Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0749-2016·Announced 2016-02-10

bioMérieux Recalls BacT/ALERT SN Culture Bottles Due to Shipping Exposure

bioMérieux is recalling 2,741 BacT/ALERT SN culture bottles because non-normal shipping conditions may have degraded the media, potentially impacting microbial growth performance.

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 is a theoretical performance issue (media degradation) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

bioMérieux, Inc. is recalling 2,741 units of BacT/ALERT SN culture bottles. These products are used with the BacT/ALERT Microbial Detection System for the qualitative detection of aerobic and facultative anaerobic microorganisms, including bacteria and yeast.

The recall was initiated because the bottles may have been exposed to non-normal shipping conditions. This exposure may have led to media degradation, which could impact the growth performance of the culture bottles.

The affected products have the reference number 259790, lot number 1042739, and an expiry date of 09JAN2016. The units were distributed in 31 countries, including France, Germany, Italy, Spain, and the United Arab Emirates. Users should stop using the affected bottles and contact the manufacturer for further instructions.

The recalled product

Product: BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
Manufacturer: bioMerieux, Inc.
Category: Medical Device — Laboratory Diagnostics
Hazard: performance-degradation
Affected units: 2,741

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)

Reference number: 259790
Lot number: 1042739
Expiry: 09JAN2016.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · bioMerieux, Inc.

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