AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The Quic...

FDA Device Recall #Z-2138-2014 — Class II — July 4, 2014

Recall Summary

Recall Number Z-2138-2014
Classification Class II — Moderate risk
Date Initiated July 4, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Advandx Inc
Location Woburn, MA
Product Type Devices
Quantity 10 kits

Product Description

AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)

Reason for Recall

Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC

Distribution Pattern

Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.

Lot / Code Information

Lot Number: 04914 Exp. Date: 2015-06

Other Recalls from Advandx Inc

Recall # Classification Product Date
Z-0112-2013 Class II AdvanDx GNR Traffic Light PNA FISH, In Vitro Di... Sep 14, 2012
Z-0116-2013 Class II AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitr... Sep 14, 2012

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.