ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantit...
FDA Device Recall #Z-1529-2017 — Class II — December 15, 2016
Recall Summary
| Recall Number | Z-1529-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 15, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | BioMerieux SA |
| Location | Marcy L'Etoile |
| Product Type | Devices |
| Quantity | unknown |
Product Description
ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions
Reason for Recall
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Distribution Pattern
Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia
Lot / Code Information
Reference no. 513610, Lot #1001125240 & 1001610770; Reference no. 513618, Lot #1001193130, 1001223300, 1001316710, 1001377740, 1001454060, 1001454090, 1001527340, 1001633670, 1001721100, 1001801280, 1001804930, 1002029820, 1002234950, 1002238110, 1002269280, 1002476170, 1002593870, 1002699130, 1002702380 & 1003066070; Reference no. 513658, Lot #1001154880, 1001265150, 1001368000, 1001390590, 1001487630, 1001609830, 1001676400, 1001735190, 1001811380, 1002056670, 1002230910, 1002478800, 1002596830 & 1003066090 and Reference no. 513650, Lot #1001135740, 1001154700, 1001251110, 1001319240, 1001333960, 1001409550, 1001557360, 1001574370.
Other Recalls from BioMerieux SA
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0084-2022 | Class II | MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2... | Sep 2, 2021 |
| Z-2225-2021 | Class II | MYLA software. Used to manage microbiology tes... | Jun 22, 2021 |
| Z-0218-2019 | Class II | NucliSENS¿ Magnetic Extraction Reagents | Sep 17, 2018 |
| Z-2331-2018 | Class II | VIDAS FSH, Ref 30407-01, IVD, Rx. The firm nam... | Apr 9, 2018 |
| Z-2169-2018 | Class II | VIDAS TOXO IgG Avidity is an automated qualitat... | Mar 23, 2018 |
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.