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FDA Device Recall #Z-1068-2018 — Class II — October 25, 2017

Recall Summary

Recall Number Z-1068-2018
Classification Class II — Moderate risk
Date Initiated October 25, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

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

Product Description

STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).

Reason for Recall

Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

Distribution Pattern

Nationally

Lot / Code Information

Lot 251064 (Exp: 09-2018) Lot 251725 (Exp: 02-2019)

Other Recalls from Diagnostica Stago, Inc.

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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.