Z-1483-2024 Class II Ongoing
FDA device recall Z-1483-2024 was initiated by Microbiologics Inc on March 6, 2024 and is designated Class II. 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. brasiliens… The recall status is ongoing. Affected quantity: 19 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2024
- Initiation Date
- March 6, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
Product Description
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
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 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.
Code Information
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