FDA recall, , Moderate risk
STA Liatest D-Di
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Summary by Recall Canary from the FDA notice
What happened
Diagnostica Stago, Inc., of Parsippany, New Jersey, is recalling the STA Liatest D-Di kit, an immuno-turbidimetric assay for quantitative D-dimer determination in venous plasma, after customer complaints and investigations confirmed a positive bias in D-Dimer measurements throughout the entire analytical range.
The recall began on February 5, 2026, and was added to the FDA's Enforcement Report on March 19, 2026. The product was distributed nationwide in the US and in Canada, Singapore, Guam, Japan, South Korea, and Russia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and lot code listed under your product.
STA Liatest D-Di
- Model number
- REF 00515
- Lot code
- 273015
- 273127
- 273275
- 273567
- 273681
- 273808
- 273995
- 274108
- 273128
- 273606
- 273805
- 274219
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.
- Company
- Diagnostica Stago, Inc.Parsippany, New Jersey
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98362
- Recall number
- Z-1585-2026
- Quantity recalled
- 34000 units (28446 US, 5554 OUS)
All recalls from Diagnostica Stago, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
