Agency classClass IIOur severity:High FDA (Devices)·Z-3180-2018·Announced 2018-09-26

bioMerieux Recalls VITEK 2 AST-P655 Cards Due to Gentamicin Error

bioMerieux is recalling VITEK 2 AST-P655 cards because six lots were manufactured with insufficient gentamicin, potentially affecting high-level resistance screening results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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 and involves a risk-of-harm product (medical device) where the hazard is a potential diagnostic error rather than a direct physical injury, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

bioMerieux, Inc. is recalling 10,919 cartons of VITEK 2 AST-P655 cards used for antimicrobial susceptibility testing. The recall was initiated after a routine internal review of device history records identified that six specific lots were manufactured with less gentamicin than required for the Gentamicin High-Level Resistance (ghlr01n) screen test. This manufacturing error occurred during the preparation of 1500mL and 2000mL media well solutions.

The affected lots are 8050348103, 8050452403, 8050655403, and 8050690403. These products were distributed worldwide, including in the United States, Turkey, Austria, Switzerland, the Czech Republic, Germany, and the Netherlands. The VITEK 2 system is an automated platform used in clinical laboratories to identify bacteria and test their susceptibility to antimicrobials.

Healthcare facilities and laboratories should stop using the affected lots and contact bioMerieux for instructions on returning or replacing the products. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the…
Manufacturer: bioMerieux, Inc.
Category: Medical Device — Laboratory Diagnostic
Hazard: mis-labeling
diagnostic-error
Affected units: 10,919

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 (4)

Lot Numbers: 8050348103
8050452403
8050655403
8050690403

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · bioMerieux, Inc.

See all →

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Severe
VITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
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Same hazard · mis labeling