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U.S. Department of Health and Human Services

Class 2 Device Recall Roche Diagnostics

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  Class 2 Device Recall Roche Diagnostics see related information
Date Initiated by Firm February 04, 2019
Create Date May 17, 2019
Recall Status1 Terminated 3 on September 16, 2020
Recall Number Z-1368-2019
Recall Event ID 82139
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Cobas¿ infinity central lab IT solution
Material Number: 07154003001

Calculator/Data Processing Module, For Clinical Use
Code Information Software versions 2.0 thorough 2.5 Serial Numbers: 81191 81371 81385 81465 81469 81470 81481 81485 81527 81528 81618 81628 81652 81655 81662 
Recalling Firm/
Manufacturer		 Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Support Network
800-526-2272
Manufacturer Reason
for Recall		 Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.
FDA Determined
Cause 2		 Software design
Action Roche Diagnostics issued on 2/04/19 an "URGENT MEDICAL DEVICE CORRECTION"(UMDC) letter to its customers via UPS Ground (receipt required). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: " When using the automated bottle change function, ensure Good Laboratory Practices (GLP) are being followed (i.e., all QC results for the current and standby bottles are in range and are not flagged prior to testing patient samples). " Complete the attached fax form (TP-00548) and fax this form to 1-866-608-3939 or email it to Roche10042@stericycle.com. " When a new software version is available, a Roche representative will contact you to schedule the software update. " File this UMDC for future reference. Contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-526-2272 if you have questions
Quantity in Commerce 15 units
Distribution US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX.
Total Product Life Cycle TPLC 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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