Recall Z-1691-2020
Microbiologics Inc · initiated February 12, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770, (17)200831, (10)5195-04.
Codes / lots: Catalog Number: 5195P (KWIK-STIK kit that contains 0778P). Lot Numbers: 5195-04, 5195-05. UDI 70845357030770.
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Microbiologics notified customer on 02/12/2020 via "Urgent Medical Device Correction" letter. The recall letter was emailed to consignees and the consignees were instructed to properly discard any affected products they have. The recall letter identified the affected product and lot numbers. Reason for the correction was also noted in the recall letter.
Details
- Recall number
- Z-1691-2020
- Initiated
- February 12, 2020
- Terminated
- March 26, 2021
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 49 units
- Distribution
- Nationwide, Including Australia, Brazil, Curacao, Ecuador, Germany, Greece, Italy, Puerto Rico, Singapore, Turkey, United States, Uruguay and Australia.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1690-2020 Class II | KWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot…KWIKSTIK 2 Pack (REF 0778P) and QC Set and Panels: KWIKSTIK YST Comprehensive QC Set (REF 5195P) contain… | 02/12/2020Terminated |