AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Esche...
FDA Device Recall #Z-0116-2013 — Class II — September 14, 2012
Recall Summary
| Recall Number | Z-0116-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 14, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Advandx Inc |
| Location | Woburn, MA |
| Product Type | Devices |
| Quantity | 33 units |
Product Description
AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.
Reason for Recall
Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive signal
Distribution Pattern
Worldwide distribution: USA (nationwide) including: CA, FL, IL, MI, and NJ; and country of: Great Britain.
Lot / Code Information
Lot Numbers: 01812A-US, 03412A-US and 00512A-EU Exp Date: 12-2013
Other Recalls from Advandx Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2138-2014 | Class II | AdvanDx Quick FISH Fixation Kit for BC ( Blood ... | Jul 4, 2014 |
| Z-0112-2013 | Class II | AdvanDx GNR Traffic Light PNA FISH, In Vitro Di... | 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.