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Microbiologics KWIK-STIK QC Kit Recalled for Mislabelled Lot Packaging (2025)

Microbiologics recalled 5 KWIK-STIK quality control kits for culture media after发现 some kits labeled for lot 818-111-7 were packed in pouches marked as lot 857-53-10. The mislabeling could affect quality control results for Vibrio parahaemolyticus tests derived from ATCC 17802. Laboratories and healthcare facilities should stop using the kit and follow the manufacturer’s recall instructions.

Official notice
MicrobiologicsHealth & Personal CareMedical DevicesUDI-DI: 30845357020018Lot Number: 818-111-7

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
November 13, 2025
Status
ACTIVE
Severity
5/10

Quick Facts at a Glance

Recall Date
November 13, 2025
Hazard Level
HIGH
Brand
Microbiologics
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Microbiologics
Product type
Quality control kit for culture media
Model numbers
UDI-DI: 30845357020018, Lot Number: 818-111-7
Sold at
Unknown

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    November 13, 2025

  2. Reported by FDA DEVICE

    December 10, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Microbiologics Inc or your healthcare provider for instructions. Notification method: Letter

About This Product

KWIK-STIK is a quality control kit used to verify culture media performance, including Vibrio parahaemolyticus derived from ATCC 17802. Laboratories rely on QC kits to ensure accurate test results.

Why This Is Dangerous

Mislabeling of pouch lots could lead to incorrect identification of QC materials and potentially inaccurate culture test results.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

The impact is primarily on laboratory QC accuracy. No consumer injuries are reported, but incorrect QC results could affect downstream diagnostic decisions.

Practical Guidance

How to identify if yours is affected

  1. Check Catalog Number 0818K
  2. Review Lot Number on pouch labeling for 818-111-7
  3. Look for pouch labels that may read 857-53-10 instead
  4. Verify UDI-DI 30845357020018 on the package

Where to find product info

Lot numbers and UDI-DI are printed on the pouch and outer packaging; Catalog Number is on the label

What timeline to expect

Refunds or replacements, if available, typically processed within 4-8 weeks after confirmation

If the manufacturer is unresponsive

  • Document all contacts with Microbiologics
  • Escalate to regulatory authorities if the company is unresponsive
  • Consider filing a consumer protection complaint if necessary

How to prevent similar issues

  • Inspect packaging labels carefully at receipt
  • Maintain an inventory log by lot and label
  • Follow supplier recall notices promptly
  • Verify QC materials against the lot before use in critical testing

Documentation advice

Keep all packaging, labeling, recall notices, and correspondence with Microbiologics for records and potential claims

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Product Details

Catalog Number: 0818K. UDI-DI: 30845357020018. Lot Number: 818-111-7. Quantity: 5 units. Countries distributed to: UAE, China, Singapore, Kazakhstan. Sold since: Unknown. Estimated price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Lot 818-111-7 potentially packaged as Lot 857-53-10
  • International distribution to UAE, China, Singapore, Kazakhstan

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
5/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
UDI-DI: 30845357020018
Lot Number: 818-111-7
Report Date
December 10, 2025
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

Microbiologics Recalls KWIK-STIK Over Testing Failure Risk

Microbiologics recalled 86 units of the KWIK-STIK 2-Pack on December 2, 2025. The affected products may fail to recover the target microorganism Campylobacter jejuni. This recall affects units distributed worldwide, including the U.S.

Microbiologics
Affected units
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