PlainRecalls
FDA Devices Moderate Class II Ongoing

KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media

Reported: April 17, 2024 Initiated: March 6, 2024 #Z-1483-2024

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.

Details

Recalling Firm
Microbiologics Inc
Units Affected
19 units
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.
Location
Saint Cloud, MN

Frequently Asked Questions

What product was recalled?
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media. Recalled by Microbiologics Inc. Units affected: 19 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 17, 2024. Severity: Moderate. Recall number: Z-1483-2024.