CLASS III Device recall · Reported 30 Jan 2013 · FDA Enforcement Report
Roche Cobas Integra 400 and 400 plus Analyzer recalled
Roche Diagnostics Operations is recalling Roche Cobas Integra 400 and 400 plus Analyzer, an in vitro diagnostic analyzer, distributed nationwide in the US. The recall was initiated on 19 Nov 2012 and the FDA has classified it as Class III.
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-0696-2013
- FDA event ID
- 63617
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Nov 2012
- FDA classified
- 18 Jan 2013
- Reported
- 30 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 19 Nov 2012 | Recall initiated by company | |
| 18 Jan 2013 | Classified by FDA | +60 days |
| 30 Jan 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product. This means an attacker could register their own non-Roche database via remote access
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Where it was distributed
Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR.
Nationwide AlabamaArkansasArizonaCaliforniaConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesota
Questions about this recall
Is Roche Cobas Integra 400 and 400 plus Analyzer, an in vitro diagnostic analyzer recalled?
Yes. Roche Diagnostics Operations recalled Roche Cobas Integra 400 and 400 plus Analyzer, an in vitro diagnostic analyzer on 19 Nov 2012. The recall is Class III and its status is Terminated. Recall number Z-0696-2013.
Why was it recalled?
A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product. This means an attacker could register their own non-Roche database via remote access
Which lots are affected?
Part Numbers: 28065047001 and 03245233001
Where was it sold?
Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 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 Roche Diagnostics Operations
All 127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | cobas pro integrated solutions recalled by Roche Diagnostics Operations | Roche Diagnostics Operations | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | The Elecsys Anti-TSHR immunoassay is a three-step recalled | Roche Diagnostics Operations | Particulate Matter | Nationwide |
| Device | CLASS II | cobas HCYS, Homocysteine Enzymatic Assay, Material Number recalled | Roche Diagnostics Operations | Potency & Assay | 8 states |
| Device | CLASS II | Creatine Kinase (CK) used on cobas c 311/501/502 recalled | Roche Diagnostics Operations | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Tina-quant D-Dimer Test System recalled by Roche Diagnostics Operations | Roche Diagnostics Operations | Potency & Assay | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S 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 | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |