The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0582-2022·Announced 2022-02-16

Medical device reference standard contaminated with bacterial species

Microbiologics recalls KWIK-STIK Streptococcus pneumoniae reference standards due to potential contamination with Staphylococcus epidermidis, E. coli, and Staphylococcus warneri affecting 271 units worldwide.

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: FDA Class II device with no reported illnesses or injuries. The recall addresses potential contamination, a theoretical hazard. This meets the Moderate severity criterion for low-risk contamination in a precautionary recall.

Plain-English summary

Microbiologics Inc. is recalling KWIK-STIK Streptococcus pneumoniae reference standards due to potential contamination with Staphylococcus epidermidis, E. coli, and Staphylococcus warneri. A total of 271 units were distributed worldwide.

The affected product includes KWIK-STIK in 2 Pack and 6 Pack formats. Affected catalog numbers are 0947P (Lot Numbers 947-126-2 and 947-126-4) and 0947K (Lot Number 947-126-3). Distribution included multiple US states, Puerto Rico, and 26 countries internationally.

Each KWIK-STIK unit contains a lyophilized Streptococcus pneumoniae pellet, hydrating fluid, and an inoculating swab, sealed in a laminated pouch with desiccant.

The recalled product

Product
KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab.…
Manufacturer
Microbiologics Inc
Category
Medical Device — Reference Standard
Hazard
Affected units
271

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)

  • a. Catalog Number: 0947P
  • Lot Number: 947-126-2
  • 947-126-4
  • UDI: 20845357022947. b. Catalog Number: 0947K
  • Lot Number: 947-126-3
  • UDI: 30845357022951

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Microbiologics 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 →

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