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Open, Classified

KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media

FDA Recall Z-1483-2024 · Posted 2024-04-05

Recalling FirmMicrobiologics Inc
Recall StatusOpen, Classified
Product CodeJTR
Date Initiated2024-03-06
Product Quantity19 units

Reason for Recall

The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material.

Firm Action

Microbiologics issued an Urgent Medical Device Recall notice to its consignees on 03/06/2024 via email. The notice explained problem with the device and provided the following instructions: 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage. 3. COMPLETE the response form provided. 4. RETURN the response form to [email protected] 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. CONTACT Microbiologics if a replacement kit is needed. For questions contact Recall Support team at 320.229.7080 or [email protected]

Root Cause

Use error

Distribution Pattern

Worldwide - US Nationwide distribution in the states of CA, MI, KY, MO, NM, TN, PR, and the countries of France, Columbia, Kazakhstan, Peru, Puerto Rico, South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K861022KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-Logics · 1986-04-04

Official Source

View FDA Recall →

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

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