DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox...

FDA Device Recall #Z-2884-2016 — Class II — July 25, 2016

Recall Summary

Recall Number Z-2884-2016
Classification Class II — Moderate risk
Date Initiated July 25, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Microgenics Corporation
Location Fremont, CA
Product Type Devices
Quantity 1708 kits

Product Description

DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.

Reason for Recall

Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.

Distribution Pattern

Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.

Lot / Code Information

Lot Number Expiration Date 60704602 DEC 2016; 72035410 JUL 2017; 72208738 FEB 2018; 72409454 OCT 2018.

Other Recalls from Microgenics Corporation

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Z-0415-2026 Class II Thermo scientific MAS Omni CARDIO, Liquid Assay... Oct 1, 2025
Z-1284-2022 Class II QMS Tacrolimus Immunoassay REF 10015573 CALIBRA... Jan 20, 2022
Z-0008-2017 Class II Thermo Scientific QMS Everolimus Assay; Model ... Aug 15, 2016
Z-0501-2015 Class II MAS CardioImmune XL Cardiac Marker Control; Mo... Oct 20, 2014
Z-1930-2014 Class III MAS Omni Immune PRO Controls Dec 2, 2013

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.