Device product
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
Z-1483-2024
Product summary
- Event
- Event 94201
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19 units
- Official record key
device-enforcement:Z-1483-2024
Official wording
Reason: 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.
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
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.
Derived failure modes
-
Unknown
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.