Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for det...
FDA Device Recall #Z-0440-2016 — Class I — November 19, 2015
Recall Summary
| Recall Number | Z-0440-2016 |
| Classification | Class I — Serious risk |
| Date Initiated | November 19, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Biomerieux |
| Location | Letoile, N/A |
| Product Type | Devices |
| Quantity | 1216 units |
Product Description
Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
Reason for Recall
Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
Distribution Pattern
Worldwide Distribution- US Nationwide including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GS, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV and WY, and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Lithuania, Malaysia, Macedonia, Oman, Netherlands, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Singapore, Slavonia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, the United Kingdom, Vietnam and Venezuela.
Lot / Code Information
Ref. 412433, Lot numbers: 1004394540, 1003903640, 1003558430, 1003069250, 1002372580 and 1001938220
Other Recalls from Biomerieux
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0442-2016 | Class I | Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tes... | Nov 19, 2015 |
| Z-0441-2016 | Class I | Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tes... | Nov 19, 2015 |
| Z-0439-2016 | Class I | Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.0... | Nov 19, 2015 |
| Z-0233-2015 | Class III | Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (... | Oct 16, 2014 |
| Z-0230-2015 | Class III | Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (A... | Oct 16, 2014 |
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.