Agency classClass IIIOur severity:Low FDA (Devices)·Z-1125-2022·Announced 2022-06-01

Medical device labeling error: KWIK-STIK® plus Clostridium perfringens

Microbiologics Inc recalled 8 units of KWIK-STIK® plus Clostridium perfringens due to a labeling error. The affected lot (801-44-4) was distributed to laboratories in the United States and internationally.

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: This is a Class III medical device recall citing only a labeling error with no reported illnesses, injuries, or safety incidents. Per the rubric, documentation issues score 1, and this labeling error lacks the health impact or serious defect criteria for higher scores.

Plain-English summary

Microbiologics Inc recalled KWIK-STIK® plus: Clostridium perfringens, a laboratory reference material. The recall involved 8 units with catalog number 0801P and lot number 801-44-4, with an expiration date of May 31, 2023.

The product was recalled due to a labeling error. The affected units were distributed to laboratories in the United States (including Iowa and Tennessee) as well as internationally to Mexico, Colombia, France, South Africa, and the United Kingdom.

The firm initiated this voluntary recall on May 6, 2022. The FDA classified it as a Class III recall on May 23, 2022. The recall status was terminated on January 16, 2024.

Laboratory facilities that may have received this product should verify their inventory against the lot number (801-44-4) and contact Microbiologics Inc for guidance.

The recalled product

Product: KWIK-STIK" plus: Clostridium perfringens
Manufacturer: Microbiologics Inc
Category: Medical Device — Laboratory Reference Material
Hazard: mis-labeling
Affected units: 8

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)

catalog number: 0801P
lot number: 801-44-4
expiration date: 05/31/2023
UDI: 20845357019374

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Microbiologics Inc

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