Recall Z-0543-2022— Microbiologics Inc

Name: FDA recall Z-0543-2022
Creator: U.S. Food and Drug Administration
Published: 2021-02-24

Class III · Terminated

Class III FDA medical device recall by Microbiologics Inc, initiated 2021-02-24, terminated 2022-07-11. It names one FDA 510(k) clearance: K861022. Product: KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.. Reason: Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7..

Recalling firm: Microbiologics Inc
Classification: Class III
Status: Terminated
Initiated: 2021-02-24
Terminated: 2022-07-11
Firm location: Saint Cloud, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K861022 — KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-Logics·cleared 1986-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.