Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantit...
FDA Device Recall #Z-0233-2015 — Class III — October 16, 2014
Recall Summary
| Recall Number | Z-0233-2015 |
| Classification | Class III — Low risk |
| Date Initiated | October 16, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Biomerieux |
| Location | Letoile, N/A |
| Product Type | Devices |
| Quantity | 652 devices |
Product Description
Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
Reason for Recall
The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
Distribution Pattern
Worldwide Distribution-US (nationwide) including DC and the states of AL, AK, AR, AZ, CA, CO, DE, FL, GA, IA, IN, KY, MA, MD, MI, MO, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and the countries of Australia, Austria, China, Czech Republic, France, Germany, India, Italy, Japan, Netherlands, Poland, Portugal, Switzerland, Sweden, Turkey, United Kingdom, Egypt, Pakistan, Slovenia and Uruguay.
Lot / Code Information
Ref #537548, Lot #1003202820, Right Expiry date: 27-APR-2016
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-0440-2016 | Class I | Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests... | 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-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.