Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported January 30, 2013
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
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-L…
Roche Diagnostics Operations, Inc. recalled Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer. - a low-severity action.
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer. was recalled by Roche Diagnostics Operations, Inc. in January 30, 2013. Reason: A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied …. Check the official notice for the remedy. Verify recall #Z-0696-2013 with the FDA Devices before acting.
The recall
Roche Diagnostics Operations, Inc. issued this low-severity FDA Devices recall-A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied ….
- Low
- severity level
- 845 units
- affected scope
- Class III
- classification
- January 30, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0696-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0696-2013) was formally reported on January 30, 2013, with the manufacturer initiating the action on November 19, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Roche Diagnostics Operations, Inc. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 845 Units.
The documented reason for this recall is: 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 authenti… Distribution data in the federal record shows the product reached: 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 an…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
845 Units
Related Recalls
6
3 from same agency
Product description
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0696-2013 |
| Date reported | January 30, 2013 |
| Date initiated | November 19, 2012 |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Firm location | Indianapolis, IN |
| Affected scope | 845 Units |
| Distribution | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0696-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 845 Units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on January 30, 2013. Severity: Low. Recall number: Z-0696-2013.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0696-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 30, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.