Z-1585-2026Class II

Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product...

Name: Z-1585-2026 Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product...
Creator: Diagnostica Stago, Inc.
Published: 2026-02-05
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2026-02-05 / Open, Classified

FDA source

Diagnostica Stago, Inc. began a recall of Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di... on 2026-02-05. FDA classified it as Class II and gives the reason as "After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1585-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-05
Posted: 2026-03-19
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: in 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.
Product code: DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Reason for recall: After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
FDA root cause: Process change control
Action: On February 5, 2026 QUALITY ALERT letters were emailed to customers. Actions required: 1. As the intended purpose of the kit is to exclude PE and DVT, and its sensitivity and negative predictive value remain unchanged, it is appropriate to continue utilizing the reagents. 2. Please complete, sign and return the attached Acknowledgement Form by email, as directed on the form. In the event that a patient experiences an adverse event with any medical device, you may report it to FDA; see the guidance document Medical Device Reporting for User Facilities, which is available on the FDA.gov website, for instructions. For additional information, please contact Stago s 24/7 Hotline at 1-800-725-0607.
Quantity in commerce: 34000 units (28446 US, 5554 OUS)
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1585-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1585-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-25	2026-03-19

Product code DAP

K162227Class IISTA® - Liatest® D-DiDiagnostica Stago / cleared 2016-12-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)