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Terminated

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.

FDA Recall Z-0402-2021 · Posted None

Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeJTR
Date Initiated2020-10-08
Date Terminated2022-11-03
Product Quantity46 units

Reason for Recall

Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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