Medical Device Quality Control Kit Recall: Incorrect Microorganism Swabs Packaged
Microbiologics Inc is recalling KWIK-STICK quality control kits because affected packages contain the wrong microorganism swabs, which may delay diagnosis. Two catalog numbers (01065K and 0621K) were swapped in packaging.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with risk of delayed diagnosis. No illnesses or injuries have been reported. The packaging/labeling error affects diagnostic accuracy, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Microbiologics Inc is recalling certain lots of KWIK-STICK quality control kits for culture media verification. The affected products are Catalog Numbers 01065K (Oligella urethralis, lot 1065-25-51) and 0621K (Staphylococcus aureus, lot 621-73-21).
Affected packages contain swapped microorganism components. The 0621K packages contain 01065K swabs, and the 01065K packages contain 0621K swabs. This packaging error means laboratories received quality control kits with incorrect microorganism strains.
Using these products could delay diagnosis because laboratories may validate their culture media against the wrong microorganism. The kits were distributed nationwide in California and Pennsylvania, as well as to New Zealand.
Laboratories that received these affected lots should stop using them immediately and contact Microbiologics Inc for further instructions.
The recalled product
- Product
- KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
- Manufacturer
- Microbiologics Inc
- Hazard
- mis-labeling
- delayed-diagnosis
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)
- 01065K: UDI-DI 30845357032868
- lot 1065-25-51
- 0621K: UDI-DI 30845357014666
- lot 621-73-21
Distribution
Distributed nationwide across the United States.
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