FDA-Device2026-03-25Class IIPROCESSING DEFECT
Diagnostica Stago STA Liatest D-Di test kit recalled for inaccurate blood clot measurements
What this means
Diagnostica Stago's STA Liatest D-Di blood test kits are giving inaccurate measurements for D-dimer (a marker used to help rule out blood clots). The kits are showing higher-than-actual results across all test ranges. These kits are used in hospital and reference laboratories on specific analyzer machines.
- If you operate a laboratory, check whether you have any affected lot numbers (273015, 273127, 273275, 273567, 273681, 273808, 273995, 274108, 273128, 273606, 273805, or 274219).
- Stop using affected kits immediately and contact Diagnostica Stago for replacement or guidance.
- Review recent test results if you have concerns about accuracy.
The agency's original wording
Hazard
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.
Affected count
34000 units (28446 US, 5554 OUS)
Manufactured in
5 Century Dr, N/A, Parsippany, NJ, United States
Products
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1585-2026More Diagnostica Stago recalls
- FDA-Device2026-09-09Diagnostica Stago STA Staclot Protein S reagent recalled for QC drift
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.