CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report

Vitek¿ Negative Susceptibility card (Ast-N232) recalled by Biomerieux

Biomerieux is recalling Vitek¿ Negative Susceptibility card (Ast-N232), distributed nationwide in the US. The recall was initiated on 20 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes6320117203 23/Mar/18 6320125203 31/Mar/18

Quantity recalled2,499 cartons

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-2403-2017
FDA event ID: 77026
Recalling firm: Biomerieux, Hazelwood, MO
Classification: Class II
Status: Terminated
Recall initiated: 20 Apr 2017
FDA classified: 13 Jun 2017
Reported: 21 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

20 Apr 2017	Recall initiated by company
13 Jun 2017	Classified by FDA	+54 days
21 Jun 2017	Published in enforcement report	+8 days

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

Reason for recall

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

VITEK¿ 2 Gram Negative Susceptibility card (AST-N232), REF 413116, 20 cards per carton.

Where it was distributed

Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.

Nationwide Georgia

Questions about this recall

Is Vitek¿ Negative Susceptibility card (Ast-N232) recalled?

Yes. Biomerieux recalled Vitek¿ Negative Susceptibility card (Ast-N232) on 20 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-2403-2017.

Why was it recalled?

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Which lots are affected?

6320117203 23/Mar/18 6320125203 31/Mar/18

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

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