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.
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: 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. E
- Manufacturer
- Microbiologics Inc
- Hazard
- bacterial-contamination
- e-coli
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.
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