Agency classClass IIIOur severity:Low FDA (Devices)·Z-1401-2015·Announced 2015-04-15

Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Cards Due to Labeling Error

Biomerieux Inc is recalling Vitek 2 AST-P635 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended organism.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding intended use, fitting the criteria for a Low severity score.

Plain-English summary

Biomerieux Inc is recalling 10,409 cartons of Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Cards. These in vitro diagnostic (IVD) cards are intended for use with Vitek 2 Systems in clinical laboratories to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.

The recall was initiated because the outer carton label and package insert incorrectly list Streptococcus pneumoniae as an organism for intended use. The affected lots include 735352820, 735348620, 735346520, 735342320, 735318020, 735315920, 735323710, and 735310210, with expiration dates ranging from June 2015 to August 2016.

The product was distributed worldwide to the United Kingdom and Turkey. There was no U.S. distribution of the recalled product. Clinical laboratories should stop using the affected cards and contact Biomerieux Inc for instructions on return or disposal.

The recalled product

Product: Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
Manufacturer: Biomerieux Inc
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
Affected units: 10,409

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 (16)

lot 735352820
expiration 11AUG16
lot 735348620
expiration 30JUN16
lot 735346520
expiration 09JUN16
lot 735342320
expiration 28APR16
lot 735318020
expiration 29AUG15
lot 735315920
expiration 08AUG15
lot 735323710
expiration 25OCT15
lot 735310210
expiration 12JUN15

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Biomerieux Inc

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Same hazard · mis labeling