HIGH

Diagnostica Stago Recalls D-Dimer Test Due to Underestimation Risk

Diagnostica Stago recalled 12,740 D-Dimer testing devices on September 12, 2025. The recall follows a risk of underestimating D-Dimer levels in patients. Healthcare providers and patients should stop using the device immediately.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brand
Diagnostica Stago
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Diagnostica Stago, Inc. or your healthcare provider for instructions. Notification method: E-Mail

Product Details

The recalled product is the STA Liatest D-Di, REF: 00515. The affected lot numbers are 271382 and 271411, with an expiration date of September 30, 2025. The devices were distributed worldwide, including throughout the U.S. and Canada.

The Hazard

The recall addresses a significant risk of underestimating D-Dimer levels with the affected lots. D-Dimer tests are crucial for diagnosing blood clots, and inaccurate results may lead to serious health consequences.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. However, underestimating D-Dimer levels can result in misdiagnosis of conditions like deep vein thrombosis or pulmonary embolism.

What to Do

Stop using the device immediately. Follow recall instructions provided by the manufacturer. Contact Diagnostica Stago, Inc. or your healthcare provider for further guidance.

Contact Information

For more information, contact Diagnostica Stago at the number provided in the recall notification. Further details are available on the FDA's website.

Key Facts

  • Recall date: September 12, 2025
  • Quantity: 12,740 units
  • Affected lot numbers: 271382, 271411
  • Expiration date: September 30, 2025
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeD-Dimer Testing Device
Sold At
Multiple Retailers

Product Details

Model Numbers
REF: 00515
UDI-DI: 03607450005158
Lot numbers: 271382
271411
Expiration 09/30/2025
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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