Diagnostica Stago, Inc.: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- Recalling firm
- Diagnostica Stago, Inc.
- 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
- Reason
- After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-05
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/bf5bf936-d4e1-404c-ada8-34e6a92fe4b4