KWIK-STIK Unit (Microbiologics) – Strain Identification Error (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Catalog 5226P, Lots 5226-03, 5226-04, 5226-05, 5226-06, 5226-07 UDI: 70845357037335
Products Sold
Catalog 5226P, Lots 5226-03, 5226-04, 5226-05, 5226-06, 5226-07 UDI: 70845357037335
Microbiologics Inc is recalling Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and due to QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
Recommended Action
Per FDA guidance
The recalling firm is sending consignees recall notification letters beginning 10/08/2020 via email. The correction communication was first extended to the first level of the distribution change (those who received product directly from Microbiologics). Distributors outside of the US will be contacted via email, and if follow up is necessary, the recalling firm's international sales team will work with each distributor to ensure this communication is extended to their end users. The recalling firm is working with its European Authorized Representative to coordinate this field safety corrective action in the EU.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026