Recall record at a glance
| Official record | Z-1690-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Microbiologics Inc. |
| Report date | Apr 15, 2020 |
| Recall initiation date | Feb 12, 2020 |
| Quantity | 49 units |
| Location | Saint Cloud, MN, United States |
Official product description
KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot 778-65-3)
Why the product was recalled
KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain product labeled as Trichosporon dermatis (T. dermatis) which may contain Candida Utilis instead of T. dermatis.
Distribution information
Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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