Roche Diagnostics Corporation: Medical Device Recall in 2017 - (Recall #: Z-1763-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx

Product Classification:

Class II

Date Initiated: March 1, 2017

Date Posted: April 19, 2017

Recall Number: Z-1763-2017

Event ID: 76628

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."

Status: Terminated

Product Quantity: 45 Units

Code Information:

Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Catalog Number: 743995400

Distribution Pattern:

Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None

Voluntary or Mandated:

Voluntary: Firm initiated