KWIK-STICK Quality Control Kit for Culture Media Swab Mix-Up
Microbiologics Inc is recalling KWIK-STICK quality control kits because products were packaged with incorrect microorganism swabs, which may lead to delayed diagnosis of patient samples in clinical laboratories.
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 medical device recall where use of incorrect quality control materials could lead to delayed patient diagnosis. No illnesses or injuries are reported, but the potential for harm to patient care is significant.
Plain-English summary
Microbiologics Inc is recalling KWIK-STICK quality control kits for culture media (Catalog Numbers 01065K and 0621K) distributed nationwide to California, Pennsylvania, and New Zealand. The affected products contain incorrect microorganism assemblies: Catalog Number 0621K was packaged with Oligella urethralis swabs intended for 01065K, and Catalog Number 01065K was packaged with Staphylococcus aureus swabs intended for 0621K.
These kits are used by clinical laboratories to verify the performance of culture media. Using the wrong microorganism for quality control testing may result in delayed or inaccurate diagnosis of patient samples.
The affected lot numbers are 1065-25-51 (UDI-DI 30845357032868) for Catalog Number 01065K, and lot 621-73-21 (UDI-DI 30845357014666) for Catalog Number 0621K. Laboratories that received these products should stop using them and contact Microbiologics Inc for replacement kits with the correct microorganism assemblies.
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
- Affected units
- 3
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
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