Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-st...

FDA Device Recall #Z-1178-2014 — Class II — February 6, 2014

Recall Summary

Recall Number Z-1178-2014
Classification Class II — Moderate risk
Date Initiated February 6, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Lin-Zhi International Inc
Location Sunnyvale, CA
Product Type Devices
Quantity 130 items

Product Description

Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿ 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

Reason for Recall

Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products.

Distribution Pattern

US Distribution including the states of SC, NC, LA, FL, TX,, AL and GA and Internationally to Germany.

Lot / Code Information

Catalog number 0007Cm; lot number 1211158R; Expiration May 14, 2014.

Other Recalls from Lin-Zhi International Inc

Recall # Classification Product Date
Z-1256-2019 Class III Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (sm... Jan 11, 2019
Z-1270-2014 Class III Single Analyte DAU Calibrator (5 mL) Norbupren... Feb 18, 2014
Z-1179-2014 Class II Cannabinoids DAU Calibrator Control Level 1 (... Feb 6, 2014
Z-0386-2014 Class III Single Analyte Urine DAU Control (5 m L Norbup... Oct 3, 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.