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FDA-Device2026-03-25Class IIPROCESSING DEFECT

Diagnostica Stago STA Liatest D-Di test kit recalled for inaccurate blood clot measurements

Diagnostica Stago
OTHERNationwide distribution

Stop using STA Liatest D-Di test kits

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.
Hazard

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

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-1585-2026

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