Date Initiated by Firm |
December 14, 2018 |
Create Date |
April 10, 2019 |
Recall Status1 |
Terminated 3 on September 04, 2020 |
Recall Number |
Z-1125-2019 |
Recall Event ID |
81814 |
510(K)Number |
K024098 K873049
|
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product |
cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190;
b)Triglycerides Catalog Number: 04657594190 - 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 |
137 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.
|
510(K) Database |
510(K)s with Product Code = JJE and Original Applicant = BOEHRINGER MANNHEIM CORP. 510(K)s with Product Code = JJE and Original Applicant = ROCHE DIAGNOSTICS CORP.
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