KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
- Company
- Microbiologics Inc
- Recall Initiated
- March 6, 2024
- Posted
- April 5, 2024
- Recall Number
- Z-1483-2024
- Quantity
- 19 units
- Firm Location
- Saint Cloud, MN
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.
Distribution
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.
Lot / Code Info
a) REF 0209P, UDI/DI 20845357003113, Lot Numbers: 209-37-1, 209-37-3, 209-37-4, 209-37-5; b) REF 0209K, UDI/DI 30845357003127, Lot Numbers: 209-37-2
Root Cause
Use error
Action Taken
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 recall@microbiologics.com 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 recall@microbiologics.com