Microbiologics Inc Recalls

All product recalls associated with Microbiologics Inc.

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Recall Summary

Total Recalls

16

Past Year

10

Class I (Serious)

0

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–16 of 16 recalls

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni deri... (Microbiologics Inc) – affected units may fail to recover th... (2025)

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Moderate

FDADec 2, 2025Nationwide• Microbiologics Inc

KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni deri... (Microbiologics Inc) – affected units may fail to recover th... (2025)

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Moderate

FDADec 2, 2025Nationwide• Microbiologics Inc

LYFO DISK, Campylobacter jejuni subsp. jejuni derived fro... (Microbiologics Inc) – affected units may fail to recover th... (2025)

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Moderate

FDA

Dec 2, 2025

Nationwide

• Microbiologics Inc

KWIK-STIK, Quality control kit for culture media, Vibrio ... (Microbiologics Inc) – some products packaged for lot 818-11... (2025)

Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

Moderate

FDANov 13, 2025Nationwide• Microbiologics Inc

LYFO-DISK M. Canis (Microbiologics) – Microorganism Recovery (2025)

KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.

Moderate

FDAJun 27, 2025Nationwide• Microbiologics Inc

KWIK-STIK and LYFO DISK (Microbiologics) – Culture Media Mismatch (2025)

Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.

Moderate

FDAJun 17, 2025OH, UT• Microbiologics Inc

KWIK-STICK Control Kit (Microbiologics) – Incorrect Microorganism (2025)

Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.

Moderate

FDAMay 27, 2025Nationwide• Microbiologics Inc

Helix Elite SARS-CoV-2 Standard (Microbiologics) – Cell Target Delay (2025)

The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.

Moderate

FDAFeb 20, 2025Nationwide• Microbiologics Inc

Helix Elite Influenza Standard (Microbiologics) – RSV Target Issue (2025)

The RSV target may give a late Ct value and could potentially not pass QC.

Moderate

FDAFeb 20, 2025Nationwide• Microbiologics Inc

HPV Control Panel (Microbiologics) – quality control issue (2025)

Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.

Moderate

FDAJan 20, 2025Nationwide• Microbiologics Inc

Microbiologics Inc: KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b...

The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material.

Moderate

FDAMar 6, 2024Nationwide• Microbiologics Inc

Microbiologics Inc: Microbiologics Enteric Pathogens Control Panel (Inactivat...

The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative control.

Moderate

FDAJan 8, 2024Nationwide• Microbiologics Inc

Microbiologics Inc: LYFO-DISK, P. venetum, Catalog number 0794L

A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

Moderate

FDAOct 18, 2023Nationwide• Microbiologics Inc

Microbiologics Inc: KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack)...

A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

Moderate

FDAOct 18, 2023Nationwide• Microbiologics Inc

Microbiologics Inc: KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiolog...

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

Moderate

FDAAug 14, 2023Nationwide• Microbiologics Inc

Microbiologics Inc: Cepheid Xpert C. difficile/Epi Control Panel

Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.

Moderate

FDAMay 16, 2019CO, GA, MN +8 more• Microbiologics Inc

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Microbiologics Inc Recalls

Recall Summary

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni deri... (Microbiologics Inc) – affected units may fail to recover th... (2025)

KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni deri... (Microbiologics Inc) – affected units may fail to recover th... (2025)

LYFO DISK, Campylobacter jejuni subsp. jejuni derived fro... (Microbiologics Inc) – affected units may fail to recover th... (2025)

KWIK-STIK, Quality control kit for culture media, Vibrio ... (Microbiologics Inc) – some products packaged for lot 818-11... (2025)

LYFO-DISK M. Canis (Microbiologics) – Microorganism Recovery (2025)

KWIK-STIK and LYFO DISK (Microbiologics) – Culture Media Mismatch (2025)

KWIK-STICK Control Kit (Microbiologics) – Incorrect Microorganism (2025)

Helix Elite SARS-CoV-2 Standard (Microbiologics) – Cell Target Delay (2025)

Helix Elite Influenza Standard (Microbiologics) – RSV Target Issue (2025)

HPV Control Panel (Microbiologics) – quality control issue (2025)

Microbiologics Inc: KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b...

Microbiologics Inc: Microbiologics Enteric Pathogens Control Panel (Inactivat...

Microbiologics Inc: LYFO-DISK, P. venetum, Catalog number 0794L

Microbiologics Inc: KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack)...

Microbiologics Inc: KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiolog...

Microbiologics Inc: Cepheid Xpert C. difficile/Epi Control Panel