CLASS II Device recall · Reported 7 Feb 2018 · FDA Enforcement Report
Roche / Hitachi Modular Analyzer Systems-Immunoassay Analyzer recalled
Roche Diagnostics is recalling Roche / Hitachi Modular Analyzer Systems-Immunoassay Analyzer, distributed nationwide in the US. The recall was initiated on 5 Jul 2017 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-0499-2018
- FDA event ID
- 78756
- Recalling firm
- Roche Diagnostics, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jul 2017
- FDA classified
- 1 Feb 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Jul 2017 | Recall initiated by company | |
| 1 Feb 2018 | Classified by FDA | +211 days |
| 7 Feb 2018 | Published in enforcement report | +6 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 malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Roche / Hitachi Modular Analyzer Systems-Immunoassay Analyzer recalled?
Yes. Roche Diagnostics recalled Roche / Hitachi Modular Analyzer Systems-Immunoassay Analyzer on 5 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0499-2018.
Why was it recalled?
A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
Which lots are affected?
none
Where was it sold?
Nationwide Distribution
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 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.
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