CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report
Cobas 8100 bi-directional reformatter (BRF) module recalled
Roche Diagnostics is recalling Cobas 8100 bi-directional reformatter (BRF) module, distributed in 16 states. The recall was initiated on 1 Mar 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-1763-2017
- FDA event ID
- 76628
- Recalling firm
- Roche Diagnostics, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Mar 2017
- FDA classified
- 8 Apr 2017
- Reported
- 19 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Medical Software
Timeline
| 1 Mar 2017 | Recall initiated by company | |
| 8 Apr 2017 | Classified by FDA | +38 days |
| 19 Apr 2017 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
"Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (URF) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over."
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 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Where it was distributed
Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
AlabamaArkansasCaliforniaIowaIllinoisIndianaLouisianaMassachusettsMichiganMissouriNebraskaNew JerseyOhioPennsylvaniaSouth CarolinaTexas
Questions about this recall
Is Cobas 8100 bi-directional reformatter (BRF) module recalled?
Yes. Roche Diagnostics recalled Cobas 8100 bi-directional reformatter (BRF) module on 1 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1763-2017.
Why was it recalled?
"Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (URF) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over."
Which lots are affected?
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Catalog Number: 743995400
Where was it sold?
Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
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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