High FDA (Devices)·Z-2510-2017·Announced 2017-06-21

Biomerieux Recalls VITEK 2 Streptococcus Susceptibility Cards Due to Moisture Risk

Biomerieux Inc is recalling VITEK 2 Streptococcus Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.

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 a medical diagnostic device, which poses a risk of harm through inaccurate results, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Biomerieux Inc is recalling 3,277 cartons of VITEK 2 Streptococcus Susceptibility cards (AST-ST02), REF 420915. 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 and 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 affected lots are identified by the following codes and dates: 5410122203 (28/Mar/18), 5410199203 (13/Jun/18), 5410263203 (16/Aug/18), and 5410263223 (16/Aug/18). Users should check their inventory for these specific lot numbers and contact Biomerieux Inc for further instructions.

The recalled product

Product: VITEK¿ 2 Streptococcus Susceptibility card (AST-ST02), IVD, REF 420915, 20 cards per carton.
Manufacturer: Biomerieux Inc
Category: Medical Device — In Vitro Diagnostics
Hazard: moisture-exposure
loss-of-potency
Affected units: 3,277

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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Same hazard · moisture exposure