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U.S. Department of Health and Human Services

Class 2 Device Recall Cobas Integra 400 analyzers

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  Class 2 Device Recall Cobas Integra 400 analyzers see related information
Date Initiated by Firm December 14, 2018
Create Date April 10, 2019
Recall Status1 Terminated 3 on September 04, 2020
Recall Number Z-1124-2019
Recall Event ID 81814
510(K)Number K101203  K013249  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product COBAS INTEGRA 400 plus analyzer used in the following assays:
a)Tina-quant Apolipoprotein A-1 ver.2
Catalog Number: 03032566122
b)Tina-quant Albumin Gen.2
Catalog Number 04469658190
c)Creatinine plus ver.2
Catalog Number 03263991190
d) riglycerides
Catalog Number :20767107322 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis Tina-quant Albumin Gen.2 Immunoturbidimetric assay for the quantitative, in vitro determination of albumin in human urine, serum, plasma, and CSF on Roche/Hitachi cobas c systems
Code Information All
Recalling Firm/
Manufacturer		 Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Support Network Customer Support Center
800-428-2336
Manufacturer Reason
for Recall		 COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
FDA Determined
Cause 2		 Device Design
Action Roche Diagnostics issued on 12/14/18 "Urgent Medical Device Correction (UMDC) via UPS Ground (receipt required) Consignee Instructions: Manually add the EWCs listed in the Urgent Medical Device Correction (UMDC) on your COBAS INTEGRA 400 plus and cobas c 111 analyzers. If customers run the test combinations requiring needle assignment (See Table on page 3 of UMDC TP-00508), run those in batch mode until the updated TAS has been loaded on the COBAS INTEGRA 400 Plus analyzer. 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.
Quantity in Commerce 656 units
Distribution US Nationwide distribution.
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 = Roche Diagnostics
510(K)s with Product Code = JJE and Original Applicant = ROCHE DIAGNOSTICS CORP.
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