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U.S. Department of Health and Human Services

Class 2 Device Recall Roche / Hitachi MODULAR Analytics Combination System

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  Class 2 Device Recall Roche / Hitachi MODULAR Analytics Combination System see related information
Date Initiated by Firm December 18, 2017
Create Date March 28, 2018
Recall Status1 Terminated 3 on April 09, 2019
Recall Number Z-1269-2018
Recall Event ID 79074
510(K)Number K953239  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry
(Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692,
03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.
Code Information None
Recalling Firm/
Manufacturer		 Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Amanda Biedess
317-445-8716
Manufacturer Reason
for Recall		 Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Roche Diagnostics Corporation issued Urgent Medical Device Correction (UMDC) notices and Fax Forms to their customers dated 12/18/2017 via UPS Ground (receipt required). Customers are encouraged to do the following Mandatory Steps to improve the vertical alignment and handling of 13 mm sample tubes and false bottom tubes: FOR cobas e 411 & cobas e 601 analyzers and MODULAR ANALYTICS E 170 module: 1) Always use Roche rack cup adapters with 13 mm tubes 2) Ensure sample tubes are straight FOR cobas e 411 disk system: 1) Always use 13 mm Sample Disk Tube Adapters (SDTAs) with 13 mm sample tubes. 2) Ensure sample tubes are straight. 3) Ensure 13 mm SDTAs are not exposed to direct sunlight. 4) If a larger diameter tube is left inserted in a 13 mm SDTA for more than 3 days, the adapter may become distorted. Do not insert smaller diameter tubes into distorted adapter as they may not align correctly. **All customers are encouraged to DISCARD Analyzer Bulletin 10-009U3. Follow the care and handling instructions for using adapters as outlined in this Urgent Medical Device Correction (UMDC) and complete & return the UMDC fax form via fax to 1-877-271-1472
Distribution US Nationwide
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.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BOEHRINGER MANNHEIM CORP.
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