Reported Mar 25, 2026 · Ongoing
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in…
Diagnostica Stago, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diagnostica Stago, Inc. · 5 Century Dr · Parsippany, NJ · 07054-4607
Is this the product you have?
- Brand NameSTA
- Liatest D-Di Product NameSTA
- Liatest D-Di Model/Catalog NumberREF 00515
- Product Descriptionin vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative determination of D-dimer in venous plasma for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel
- Lot codes and dates
- Model/Catalog NumberREF 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
- Amount recalled
- 34000 units (28446 US, 5554 OUS)
Where it was sold
- Nationwide
Why it was recalled
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
This product could cause temporary or reversible health problems — stop using it.
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