KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Summary
The FDA issued a Class III for KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing by Microbiologics Inc. Reason: One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis..
Details
Source
Device Recall
External ID
Z-2576-2023
Action Date
2023-09-20
Status
Ongoing
Category
device
Product Description
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Lot/Code Info: UDI/DI 70845357025622, Lot Number 5065-26, Exp. 07/31/2024
Quantity Affected: 4 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-14
Company
Saint Cloud, MN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Microbiologics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microbiologics Inc have FDA actions?
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2576-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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