Diagnostica Stago, Inc.
13 federal recalls on file, showing the 5 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Diagnostica Stago, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-09-09FDA-DeviceClass IIDiagnostica Stago protein S reagent recalled for QC value drift
Diagnostica Stago identified a positive drift in quality control (QC) values in one lot of STA Staclot Protein S reagent within the product's stated 4-hour stability period. This drift could affect the accuracy of test results performed during that window. The issue affects reagent Lot 273074 distributed nationwide.
- 2026-03-25FDA-DeviceClass IIStop using STA Liatest D-Di test kits
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.
- 2026-03-11FDA-DeviceClass IICheck your Protein S test results
Diagnostica Stago's STA Liatest Free Protein S testing kits (model REF 00516) may produce inaccurate results, potentially underestimating free protein S levels in normal patient samples. This affects specific lot numbers distributed nationwide and internationally. No injuries have been reported.
- 2026-01-21FDA-DeviceClass IIStop using Asserachrom HPIA lot 271288
Diagnostica Stago is recalling lot 271288 of the Asserachrom HPIA test kit, which detects antibodies related to heparin-induced thrombocytopenia (HIT type II). The affected lot may have defective test wells that produce false negative results, meaning the test could fail to detect the condition when it is present.
- 2025-10-22FDA-DeviceClass IIProduct: STA Liatest D-Di; REF: 00515;
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
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