Moderate FDA (Devices)·Z-2874-2018·Announced 2018-08-29

BioMérieux VITEK 2 NH ID Test Kit Recalled for Missing Desiccant

BioMérieux Inc. is recalling 57 cartons of VITEK 2 NH ID Test Kits because they are missing desiccant, which may affect product stability.

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 involves a missing desiccant, which is a packaging/stability issue rather than a direct contamination or structural defect causing immediate harm.

Plain-English summary

BioMérieux Inc. has initiated a voluntary recall of 57 cartons of the bioMérieux VITEK 2 NH ID Test Kit. The recall was initiated because the affected units are missing desiccant. The VITEK 2 NH ID Test Kit is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

The affected product is identified by Batch/Lot 245057043 with an expiration date of 19JUN2019. The product was distributed nationwide in the United States to the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV.

The recall was initiated on January 23, 2018, and was classified as Class II by the FDA. The recall status is currently Terminated. Users should contact BioMérieux Inc. for further instructions regarding the return or replacement of the affected product.

The recalled product

Product: bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
Manufacturer: Biomerieux Inc
Category: Medical Device — Laboratory Diagnostic
Hazard: missing-desiccant
product-stability
Affected units: 57

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)

Batch/Lot: 245057043 Exp. Date 19JUN2019

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Same manufacturer · Biomerieux Inc

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