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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS MPX TEST, CE-IVD ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA
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ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS MPX TEST, CE-IVD ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA Back to Search Results
Catalog Number 06997708190
Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is on-going; a supplemental mdr will be filed upon completion of the investigation. (b)(6). The material number for the cobas mpx test, 96 t us-ivd is 06998909190. (b)(4).
 
Event Description
A customer in (b)(6) alleged (b)(6) results for a stem cell donation tested with the cobas mpx test (lot g17787). The stem cells were transplanted and there is no indication of harm to any recipient. The investigation is on-going.
 
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Brand NameCOBAS MPX TEST, CE-IVD
Type of DeviceASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA
Manufacturer (Section D)
ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
1080 us highway 202 south
branchburg NJ 08876
MDR Report Key11958699
MDR Text Key280824282
Report Number2243471-2021-01678
Device Sequence Number1
Product Code QHO
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 07/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2022
Device Catalogue Number06997708190
Device Lot NumberG17787
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2021
Is This a Reprocessed and Reused Single-Use Device? No

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