The Recall Desk
ModerateFDA (Devices)·Z-2476-2017·Announced 2017-06-21

Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards

Biomerieux is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may allow moisture exposure, leading to antibiotic degradation and loss of potency.

What this means for you

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 involves potential loss of potency due to moisture exposure without reports of serious injury or death, fitting the Moderate severity criteria for low-risk contamination or precautionary issues.

Plain-English summary

Biomerieux Inc is recalling 1,263 cartons of VITEK 2 Gram Positive Susceptibility cards (AST-P635), REF 416911. The recall is due to a potential compromise in the integrity of the product container, which may expose the product to moisture. This exposure could 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, as well as to numerous international locations. The recall covers specific lot codes 7350166103 (dated 11/May/18) and 7350291103 (dated 13/Sep/18).

Users of these in vitro diagnostic (IVD) cards should check their inventory for the affected reference number and lot codes. If the product is found, it should be removed from use and returned to the supplier or Biomerieux Inc according to their instructions.

The recalled product

Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P635), IVD, REF 416911, 20 cards per carton.
Manufacturer
Biomerieux Inc
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
1,263

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 (1)

  • 7350166103 11/May/18 7350291103 13/Sep/18

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 →

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Same hazard · moisture exposure

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