Z-1764-2017Class II

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

Name: Z-1764-2017 Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Creator: Roche Diagnostics Corporation
Published: 2017-03-01
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2017-03-01 / Terminated / root cause: software

FDA source

Roche Diagnostics Corporation began a recall of Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx on 2017-03-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1764-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-01
Posted: 2017-03-23
Terminated: 2018-07-03
Recalling firm: Roche Diagnostics GmbH
Product: Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Roche initiated a recall on 03/01/2017, notices were issued via UPS to customers and instructed customers to do the following: Roche is developing software version 03-01 to resolve this issue, and a Roche Representative will be contacting you in the near future to schedule an update. Until this software update is available, the rack buffering option for the BRF and URF modules must be disabled. If you are an authorized cobas 8100 automated workflow series operator, follow the steps outlined below to disable rack buffering. If your facility does not have an authorized cobas 8100 automated workflow series operator, please contact the Roche Support Network Customer Support Center at 1-800-428-2336 for further steps. If you have a major spill, set the affected module to offline and contact the Roche Support Network Customer Support Center at 1-800-428-2336. " If you are an authorized cobas 8100 automated workflow series operator, follow the steps outlined in this Urgent Medical Device Correction (UMDC) to disable rack buffering. " If your facility does not have an authorized cobas 8100 automated workflow series operator, please contact the Roche Support Network Customer Support Center at 1-800-428-2336 for further steps. " Complete the attached faxback form and fax it to 1-888-345-0024. " File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
Quantity in commerce: 45
Distribution: Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
Product codes and lots: Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Catalog Number: URF module: 07441657001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1764-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1763-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-08
Z-1764-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-08

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)