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Recall Observatory FDA recall evidence

Device product

KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.

Z-0543-2022

February 24, 2021

Class III

Product summary

Firm
Microbiologics Inc
Event
Event 89379
Status
Terminated
Classification
Class III
Quantity
65 packs (130 units)
Official record key
device-enforcement:Z-0543-2022

Official wording

Reason: Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.

Code information: Catalog Number: 0726P, Lot Number: 726-57-10, UDI: 20845357017486

Distribution pattern: Worldwide distribution - US distribution in the states of GA, MS, MT, NC, NM, NV, TN, TX, WA, WI and the countries of Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan, Mexico, Oman, Philippines, Romania, South Africa, Turkey, United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.