KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
This recall is currently active, issued April 5, 2024. It was issued by Microbiologics Inc.
- 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
- Official Source
- View on FDA website ↗
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