CELLESTIS 0592-0601

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-02-03 for CELLESTIS 0592-0601 manufactured by Cellestis Inc..

Event Text Entries

[37440761] As part of a capa investigation, it was determined that complaint number (b)(4) related to a foreign recall of a product only available in (b)(4). Due to the similarity to a us product, in an abundance of caution, qiagen is filing a report.
Patient Sequence No: 1, Text Type: N, H10


[37440762] Customer complaint received from (b)(6) reporting an increase in the rate of positives and grey zone specimens relative to past tube lots.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1122376-2016-00006
MDR Report Key5409013
Report SourceDISTRIBUTOR
Date Received2016-02-03
Date of Report2016-02-02
Date of Event2013-04-13
Date Mfgr Received2013-04-08
Device Manufacturer Date2012-10-01
Date Added to Maude2016-02-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. DONNA SOWERS
Manufacturer Street28358 CONSTELLATION ROAD UNIT 698
Manufacturer CityVALENCIA CA 91355
Manufacturer CountryUS
Manufacturer Postal91355
Manufacturer Phone2406867678
Manufacturer G1QIAGEN LLC
Manufacturer Street19300 GERMANTOWN ROAD
Manufacturer CityGERMANTOWN MD 20874
Manufacturer CountryUS
Manufacturer Postal Code20874
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCELLESTIS
Generic NameQUANTIFERON TB GOLD
Product CodeNCD
Date Received2016-02-03
Catalog Number0592-0601
Lot NumberA1210004
Device Expiration Date2014-01-01
OperatorMEDICAL TECHNOLOGIST
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCELLESTIS INC.
Manufacturer Address28358 CONSTELLATION ROAD UNIT 298 VALENCIA CA 91355 US 91355


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-03

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