4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes c...

FDA Device Recall #Z-1923-2016 — Class II — April 26, 2016

Recall Summary

Recall Number Z-1923-2016
Classification Class II — Moderate risk
Date Initiated April 26, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Greiner Bio-One North America, Inc.
Location Monroe, NC
Product Type Devices
Quantity 250,800 pieces (209 cases)

Product Description

4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate

Reason for Recall

The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.

Distribution Pattern

Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico

Lot / Code Information

Lot A151137L

Other Recalls from Greiner Bio-One North America, Inc.

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Z-0408-2026 Class II Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation s... Aug 8, 2025
Z-2375-2024 Class II VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Ac... May 14, 2024
Z-0733-2024 Class II VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium... Dec 12, 2023
Z-1583-2023 Class II greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, ... Mar 31, 2023

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.