Recall Z-1483-2024— Microbiologics Inc
Class II · Ongoing
Class II FDA medical device recall by Microbiologics Inc, initiated 2024-03-06. It names one FDA 510(k) clearance: K861022. Product: KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media. 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..
- Recalling firm
- Microbiologics Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-06
- Firm location
- Saint Cloud, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.