CLASS II Device recall · Reported 8 May 2019 · FDA Enforcement Report
cobas e 801 immunoassay analyzer recalled by Roche Diagnostics
Roche Diagnostics is recalling cobas e 801 immunoassay analyzer, distributed in 26 states. The recall was initiated on 15 Mar 2019 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-1249-2019
- FDA event ID
- 82394
- Recalling firm
- Roche Diagnostics, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2019
- FDA classified
- 2 May 2019
- Reported
- 8 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Mar 2019 | Recall initiated by company | |
| 2 May 2019 | Classified by FDA | +48 days |
| 8 May 2019 | 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
The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.
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
cobas e 801 immunoassay analyzer
Where it was distributed
Distributed to accounts in AL AZ CA CT FL HI IA IL IN KY LA MA MD ME MI MN MO NC NH NJ NY OH OR PA PR SC TN TX VA WA WI
AlabamaArizonaCaliforniaConnecticutFloridaIowaIllinoisKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNew HampshireNew JerseyNew YorkPennsylvaniaPuerto Rico
Questions about this recall
Is cobas e 801 immunoassay analyzer recalled?
Yes. Roche Diagnostics recalled cobas e 801 immunoassay analyzer on 15 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1249-2019.
Why was it recalled?
The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.
Which lots are affected?
All units may experience this issue.
Where was it sold?
Distributed to accounts in AL AZ CA CT FL HI IA IL IN KY LA MA MD ME MI MN MO NC NH NJ NY OH OR PA PR SC TN TX VA WA WI
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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