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

Is my product affected?

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

• UPC 07441657001

Check against the official notice below — it lists the full affected range.

What happened

Roche Diagnostics Corporation initiated a voluntary correction for Cobas 8100 uni-directional and bi-directional reformatter modules with software version 02-xx. A rack crash may occur on these modules when rack buffering is activated and the rack buffer is completely full, which can cause sample spillage and pose a risk to laboratory staff through exposure to potentially infectious material. The issue may also lead to cross-contamination of samples in affected racks and erroneous test results from sample carry-over. Forty-five affected units were distributed across 16 U.S. states including Massachusetts, Indiana, Alabama, Ohio, Missouri, Nebraska, Louisiana, California, Iowa, New Jersey, Arkansas, Pennsylvania, South Carolina, Illinois, Texas, and Michigan.

The source record does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 (BRF) 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.

Details from the source

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 (BRF) 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. Distribution: Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None Quantity: 45 Lot/code info: Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Catalog Number: URF module: 07441657001

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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