High FDA (Devices)·Z-2341-2017·Announced 2017-06-21

Biomerieux Recalls VITEK 2 Gram-Negative Identification Cards Due to Moisture Risk

Biomerieux Inc is recalling VITEK 2 Gram-Negative identification cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

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 is classified as FDA Class II. The hazard involves potential loss of potency in an in vitro diagnostic device, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Biomerieux Inc is recalling 177,828 cartons of VITEK 2 Gram-Negative identification cards (GN), IVD, REF 21341. The recall was initiated because the integrity of the product container may be compromised, which could expose the product to moisture. This exposure may lead to antibiotic degradation, resulting in a loss of potency.

The affected product was distributed nationwide in the U.S., including to military and government sites. It was also distributed to numerous international locations, including 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.

The recall covers specific lot numbers with expiration dates ranging from October 17, 2017, to March 13, 2018. Users should check their inventory for the affected lot numbers listed in the official recall notice and stop using the product if it matches the recalled lots.

The recalled product

Product: VITEK¿ 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.
Manufacturer: Biomerieux Inc
Category: Medical Device — In Vitro Diagnostics
Hazard: moisture-exposure
loss-of-potency
Affected units: 177,828

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 187 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 187 products in this recall →

Same manufacturer · Biomerieux Inc

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