Recall Z-2576-2023— Microbiologics Inc

Name: FDA recall Z-2576-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-14

Class III · Ongoing

Class III FDA medical device recall by Microbiologics Inc, initiated 2023-08-14. It names one FDA 510(k) clearance: K861022. Product: KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing. Reason: One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis..

Recalling firm: Microbiologics Inc
Classification: Class III
Status: Ongoing
Initiated: 2023-08-14
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, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing

Reason for recall

One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.

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