Roche Diagnostics product recalled over injury risk

Recall date

March 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Roche Diagnostics Corporation recalls Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx

Recall number

Z-1763-2017

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

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

Why it was 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."

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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