CLASS II Device recall · Reported 10 Feb 2016 · FDA Enforcement Report

BacT/Alert¿ FA, bioM¿rieux, Inc recalled by bioMerieux

bioMerieux is recalling BacT/Alert¿ FA, bioM¿rieux, Inc. The recall was initiated on 24 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesReference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.

Quantity recalled2741 units in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0750-2016
FDA event ID: 73027
Recalling firm: bioMerieux, Durham, NC
Classification: Class II
Status: Terminated
Recall initiated: 24 Dec 2015
FDA classified: 3 Feb 2016
Reported: 10 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

24 Dec 2015	Recall initiated by company
3 Feb 2016	Classified by FDA	+41 days
10 Feb 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

BacT/ALERT¿ FA, 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).

Where it was distributed

Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.

Questions about this recall

Why was it recalled?

Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.

Which lots are affected?

Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 73027

This product is part of a recall event; the main page for the event is BacT/Alert¿ SN, bioM¿rieux, Inc recalled by bioMerieux.

Reported	Class	Recall	Company	Reason	Where
10 Feb 2016	CLASS II	BacT/Alert¿ SN, bioM¿rieux, Inc recalled by bioMerieux	bioMerieux	Potency & Assay	NC

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