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U.S. Department of Health and Human Services

Class 2 Device Recall Cobas 8100 unidirectional reformatter (URF)

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 Class 2 Device Recall Cobas 8100 unidirectional reformatter (URF)see related information
Date Initiated by FirmMarch 01, 2017
Date PostedMarch 23, 2017
Recall Status1 Terminated 3 on July 03, 2018
Recall NumberZ-1764-2017
Recall Event ID 76628
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductCobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Code Information Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx  Catalog Number: URF module: 07441657001
Recalling Firm/
Manufacturer
Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactVince Wong
317-521-7259
Manufacturer 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.
FDA Determined
Cause 2
Under Investigation by firm
ActionRoche 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 Commerce45
DistributionDomestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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