Recall Z-1125-2022

Microbiologics Inc · initiated May 6, 2022

Class III Terminated

Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws

Product

KWIK-STIK" plus: Clostridium perfringens

Codes / lots: catalog number: 0801P; lot number: 801-44-4; expiration date: 05/31/2023; UDI: 20845357019374

Reason for recall

Labeling error.

FDA-determined cause: Labeling mix-ups

Action taken

The firm issued a recall notification to the consignees beginning on 05/06/2022 via email. The letter informs the consignee to inspect inventory, review lab procedures, use or discard affected product depending on lab procedures, and complete the response form.

Details

Recall number
Z-1125-2022
Initiated
May 6, 2022
Terminated
January 16, 2024
Product code
JTR – Kit, Quality Control For Culture Media
Quantity
8 units
Distribution
Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, United Kingdom.
Recalling firm
Microbiologics Inc, Saint Cloud, MN

Official FDA recall record