Klebsiella Pneumoniae Culture (Microbiologics) – Strain Mismatch (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism isolate.
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Catalog 01245P, Lots 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, 1245-04-1 UDI: 20845357040446
Products Sold
Catalog 01245P; Lots 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, 1245-04-1 UDI: 20845357040446
Microbiologics Inc is recalling Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used a due to Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
Recommended Action
Per FDA guidance
Communication was extended to consignees that received product directly from the recalling firm. Distributors outside of the United States will be contacted via email, and if follow-up is required, the recalling firm's international sales team will contact the distributor to ensure that this communication is extended to their end-users. The recalling firm will work with the European Authorized Representative to coordinate all field safety corrective actions for consignees in the EU. The recalling firm will conduct effectiveness checks by contacting 100% of consignees that do not respond to the correspondence. This will be completed via phone or email.
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 noticePage updated: Jan 10, 2026