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 | K013249 K101203 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = JJE 510(K)s with Product Code = JJE
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