FDA recall Z-2576-2023

Microbiologics Inc · Class III · device

Product

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.

Distribution

US Nationwide distribution in the states of MN, PA, TN, TX.

Key facts

Status
Ongoing
Initiation date
2023-08-14
Report date
2023-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2576-2023