Diagnostica Stago STA Liatest D-Di test kit recalled for inaccurate blood clot measurements
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.
From the FDA notice · Read the official notice ↗ · All Diagnostica Stago recalls
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 34000 units (28446 US, 5554 OUS)
- Illnesses reported
- None reported
- Manufactured in
- 5 Century Dr, N/A, Parsippany, NJ, United States
- Classification
- Class II
- Recall number
- Z-1585-2026
In the FDA's words
- Description
- 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 After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. Model/Catalog Number: REF 00515; UDIs: (1) (01)03607450005158(11)240630(17)250930(10)273015(241)00515, (2) (01)03607450005158(11)250325(17)260630(10)273127(241)00515, (3)(01)03607450005158(11)250416(17)260731(10)273275(241)00515, (4)(01)03607450005158(11)250527(17)260831(10)273567(241)00515, (5)(01)03607450005158(11)250618(17)260930(10)273681(241)00515, (6)(01)03607450005158(11)250716(17)261031(10)273808(241)00515, (7)(01)03607450005158(11)250716(17)261231(10)273808(241)00515, (8)(01)03607450005158(11)250909(17)261231(10)274108(241)00515 (9) (01)03607450005158(11)250326(17)260630(10)273128(241)00515, (10) (01)03607450005158(11)250429(17)260731(10)273606(241)00515, (11) (01)03607450005158(11)250709(17)261031(10)273805(241)00515, (12) (01)03607450005158(11)251007(17)270131(10)274219(241)00515; Lot numbers: (1)273015, (2)273127, (3)273275, (4)273567, (5)273681, (6)273808, (7)273995, (8)274108, (9)273128, (10)273606, (11)273805, (12)274219; Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia. Affected quantity: 34000 units (28446 US, 5554 OUS)
- Hazard
- After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
More from Diagnostica Stago
See all- Diagnostica Stago STA Staclot Protein S reagent recalled for QC drift
ModerateFDASep 9, 2026