HIGH

Oxoid Microbact 12L Kit 20 Tests Recalled for Misidentification Risk (2026)

Oxoid recalled 2 Microbact 12L Kit 20 Tests MB1128A lot 4494873 distributed nationwide in the United States, including Georgia and California. The kit may identify the wrong organism due to inconclusive color reactions in wells. Laboratories should stop using the kit immediately and follow recall instructions from Oxoid.

Quick Facts at a Glance

Recall Date
March 3, 2026
Hazard Level
HIGH
Brand
Oxoid
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.

What You Should Do

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

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About This Product

The Microbact 12L Kit is a biochemical identification system used by clinical laboratories to identify bacteria, including Listeria, based on color reactions in wells. It is used to differentiate organisms for diagnostic purposes.

Why This Is Dangerous

Ambiguous color reactions can yield inconclusive results, risking misidentification of organisms. Misidentification can lead to incorrect treatment decisions in patient care when used for clinical diagnosis.

Industry Context

This recall is not presented as part of a broader industry pattern in the notice.

Real-World Impact

Labs may need to halt testing with the affected lot, rerun identifications using alternative methods, and face potential delays in reporting results.

Practical Guidance

How to identify if yours is affected

  1. Locate MB1128A kit and confirm lot number 4494873.
  2. Check the UDI/DI 5032384127498 on the kit label.
  3. Stop using the affected kit and quarantine any remaining stock.
  4. Follow Oxoid recall instructions for refunds or replacements.

Where to find product info

FDA recall page with recall number Z-1766-2026 and Oxoid recall notice.

What timeline to expect

Not specified in the recall; follow manufacturer guidance for refunds or replacements.

If the manufacturer is unresponsive

  • Escalate to regulatory authorities if the supplier is unresponsive.
  • Document all communications and retain the recall notice.

How to prevent similar issues

  • Always verify lot numbers before use.
  • Implement alternate validated methods for critical identifications during a recall.
  • Maintain up-to-date recall notifications from suppliers.

Documentation advice

Keep copies of the recall notice, product labels, lot numbers, and all correspondence with the manufacturer or distributors.

Product Details

Model: MB1128A; UDI/DI: 5032384127498; Lot: 4494873; Sold/distributed: US nationwide, GA and CA; Recall date: 2026-03-03; Quantity: 2 kits; Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 2 kits in the US recall scope
  • Lot 4494873 MB1128A corresponds to Microbact 12L Kit 20 Tests
  • Misidentification risk due to inconclusive color reactions in wells
  • US GA and CA distribution
  • Recall status: ACTIVE as of 2026-04-08

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
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Brand
Model Numbers
MB1128A
5032384127498
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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