Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 m...

FDA Device Recall #Z-0951-2013 — Class II — January 28, 2013

Recall Summary

Recall Number Z-0951-2013
Classification Class II — Moderate risk
Date Initiated January 28, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Diagnostica Stago, Inc.
Location Parsippany, NJ
Product Type Devices
Quantity 2901 kits

Product Description

Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asni¿res sur Seine (France) Coagulation Assay

Reason for Recall

Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.

Distribution Pattern

Worldwide Distribution - USA and Canada.

Lot / Code Information

Lot/Unit Numbers : Combination of All STA-R¿/ STA-R EVOLUTION¿ and lots of STA¿ - LIATEST¿ VWF: AG are involved. Lot Number Expiry date 108128 2013-03 108512 2013-04 108778 2013-07 109415 2013-10 109591 2014-01

Other Recalls from Diagnostica Stago, Inc.

Recall # Classification Product Date
Z-1585-2026 Class II Brand Name: STA Liatest D-Di Product Name: STA... Feb 5, 2026
Z-1491-2026 Class II Brand Name: STA Liatest Free Protein S Product... Feb 4, 2026
Z-1084-2026 Class II Asserachrom HPIA. Model/Catalog Number: 00615... Dec 15, 2025
Z-0205-2026 Class II Product: STA Liatest D-Di; REF: 00515; Sep 12, 2025
Z-2473-2025 Class II STA Satellite. Product Code: All references. Al... Jul 21, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.