Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0402-2021·Announced 2020-11-11

Microbiologics Recalls Klebsiella Pneumoniae Strain Due to Incorrect VIM-1 Status

Microbiologics Inc is recalling 46 units of a Klebsiella pneumoniae strain because it is VIM-1 negative instead of the expected VIM-1 positive status.

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 2/5 (Moderate).

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, but the hazard is a labeling/identity error in a laboratory control product rather than a direct health risk to patients, fitting the 'Moderate' criteria for minor labeling errors or low-risk contamination.

Plain-English summary

Microbiologics Inc is recalling 46 units of Catalog 02145P, a Klebsiella pneumoniae strain derived from NCTC 13439. The product is intended to be used as a control to verify the performance of assays, reagents, or media used in microbial testing for the detection and identification of cultured microorganisms.

The recall was initiated because the strain was confirmed to be VIM-1 negative, whereas it should be VIM-1 positive. This discrepancy affects the reliability of the product as a control for specific microbial testing applications.

The affected units were distributed worldwide, including in the United States, Austria, Canada, Chile, China, Germany, India, Ireland, Japan, the Philippines, the United Kingdom, and Vietnam. Users of this product should stop using the affected lots and contact Microbiologics Inc for further instructions.

The recalled product

Product: Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured…
Manufacturer: Microbiologics Inc
Category: Medical Device — Laboratory Reagent
Hazard: mis-labeling
incorrect-identity
Affected units: 46

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 (6)

Catalog 01245P
Lots 1245-03-1
1245-03-2
1245-03-3
1245-03-4
1245-04-1 UDI: 20845357040446

Distribution

Distributed nationwide across the United States.

Same manufacturer · Microbiologics Inc

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