Each KWIK-STIK unit contains a lyophilized microorganism pellet — Class II medical device recall Z-0303-2021
Terminated recall by Microbiologics Inc, reported 2020-11-04. KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 posi
| Recall number | Z-0303-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2020-10-08 |
| Classified | 2020-10-27 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2022-11-17 |
| Countries outside the US | BR, CA, CR, DE, FR, GB, IE, IT, JP, NZ, SE |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 30845357036811 |
| Lot numbers | 1145-06-5 |
| Model numbers | 01145K |
Product
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
Reason for recall
KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0303-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.