Recall Z-0205-2026— Diagnostica Stago, Inc.

Name: FDA recall Z-0205-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-12

Class II · Ongoing

Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2025-09-12. It names 3 FDA 510(k) clearances: K162227, K141144, K964728. Product: Product: STA Liatest D-Di; REF: 00515;. Reason: A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots..

Recalling firm: Diagnostica Stago, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-09-12
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

3 on FDA's record

K162227 — STA® - Liatest® D-DiDiagnostica Stago·cleared 2016-12-10
K141144 — STA LIATEST D-DIDiagnostica Stago·cleared 2014-09-03
K964728 — STA-LIATEST D-DI TEST KITAmerican Bioproducts Co.·cleared 1997-06-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Product: STA Liatest D-Di; REF: 00515;

Reason for recall

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

Data sourced from openFDA. This site is unofficial and independent of the FDA.