CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP conc...

FDA Device Recall #Z-1286-2023 — Class II — February 1, 2023

Recall Summary

Recall Number Z-1286-2023
Classification Class II — Moderate risk
Date Initiated February 1, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Randox Laboratories
Location Kearneysville, WV
Product Type Devices
Quantity 2 kits

Product Description

CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826

Reason for Recall

The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range

Distribution Pattern

PA, OH, WV

Lot / Code Information

GTIN: 05055273201765 Batch: 588434

Other Recalls from Randox Laboratories

Recall # Classification Product Date
Z-2059-2018 Class II RX Imola (RX4900) For Professional Use for t... May 4, 2018
Z-0969-2018 Class III Immunoassay Premium Controls (3x4x5mL and 12x5m... Aug 11, 2017
Z-0970-2018 Class III Immunoassay Premium Plus Controls (3x4x5mL and ... Aug 11, 2017
Z-2167-2017 Class III Liquid Urine Control Level 3 For Professiona... Apr 27, 2017
Z-0762-2017 Class II The Randox Liquid Cardiac Controls Level 1, Lev... Sep 16, 2016

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.