CLASS II Device recall · Reported 8 Jul 2015 · FDA Enforcement Report
Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US recalled
BioMerieux is recalling Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic, distributed nationwide in the US. The recall was initiated on 12 Jun 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1947-2015
- FDA event ID
- 71475
- Recalling firm
- BioMerieux, Marcy L'Etoile
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2015
- FDA classified
- 1 Jul 2015
- Reported
- 8 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 12 Jun 2015 | Recall initiated by company | |
| 1 Jul 2015 | Classified by FDA | +19 days |
| 8 Jul 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
QC results were out of range resulting in false resistant strains.
Product as listed by the FDA
Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
Where it was distributed
Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.
Nationwide AlabamaArkansasCaliforniaColoradoFloridaGeorgiaIllinoisIndianaKentuckyMarylandMichiganMinnesotaMissouriNorth CarolinaNebraskaNew YorkOhioOklahomaOregonPennsylvania
Questions about this recall
Why was it recalled?
QC results were out of range resulting in false resistant strains.
Which lots are affected?
1002774320, 1002377890, 1002590470, 1002775330, 1002379610
Where was it sold?
Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from BioMerieux
All 476| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux | Biomerieux | Other | MO |
| Device | CLASS II | Vitek-negative Susceptibility Cards Containing o Polymyxin recalled | Biomerieux | Sterility | Nationwide |
| Device | CLASS II | Vitek¿-negative AST Test Kits (Cards) recalled by bioMerieux | bioMerieux | Sterility | NC |
| Device | CLASS I | Vitek 2 - AST Test kits (in vitro diagnostic test cards recalled | Biomerieux | Other | MO |
| Device | CLASS II | Myla comprises Ast Filters in conjunction with Vitek MS recalled | Biomerieux | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |