Culture media quality control kits contain the wrong bacterial organism
KWIK-STIK and LYFO DISK quality control kits for culture media are being recalled because affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. 21 units affected.
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 recall of a laboratory quality control material where the stated consequence is a failed control and delayed diagnosis rather than an incorrect patient result.
Plain-English summary
KWIK-STIK and LYFO DISK quality control kits for culture media, catalog numbers 0805K and 0805L, are being recalled. The action covers 21 units in total.
According to the manufacturer, affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. The manufacturer states this may cause the user's quality control to fail and a delayed diagnosis for the patient. The FDA classified the action as Class II.
Affected lots are 805-234-4 and 805-234-5, with UDI 30845357019531 for 0805K and 10845357019544 for 0805L. Distribution was to Utah and Ohio in the United States and internationally.
Laboratories should identify affected stock using the catalog numbers, UDI codes and lot numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
- Manufacturer
- Microbiologics Inc
- Affected units
- 21
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 (3)
- Lot #: 805-234-4
- 805-234-5 UDI: (0805K) 30845357019531
- (0805L) 10845357019544
Distribution
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