Product Wiki · Recalls · U.S. FDA — Device Enforcement

Cobas 8100 bi-directional reformatter (BRF) module with Software… — recall Z-1763-2017

U.S. FDA — Device Enforcement · United States · 2017-03-01 · Class II

As described by U.S. FDA — Device Enforcement: Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1763-2017
Date of alert
2017-03-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diagnostics Corporation
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
Reported risk: "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."
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.