Skip to content
Recall Observatory FDA recall evidence

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

March 06, 2024

Class II

Product summary

Firm
Microbiologics Inc
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

    reason.no_named_rule · v1.0.0

    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.