DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-31 for DIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL manufactured by Euro Diagnostica Ab.

Event Text Entries

[76513494] After shipment, stability test performed on the kit lot has shown that the kit functions as expected and hence the kit can be used through-out the original shelf-life. Therefore, the matter is deemed to not affect patient safety. Since the kit lot was already shipped with the shorter shelf-life, this expiry date must be adhered to, but since the new date is not stated on the alert sticker and the original kit box label remained on the kit box stating the original expiration date, it could be considered misbranding which is the reason for the recall. The recall decision was taken by the quality review board 2017-05-22. All affected countries regulatory authorities, as well as all affected euro diagnostica customers, have been notified of the recall. A field safety notice was sent out. The extent of the problem is presently deemed to be only fana200 ts 3577.
Patient Sequence No: 1, Text Type: N, H10


[76513495] Fana200 kit lot ts 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date. The alert sticker did not have the new expiration date stated on it. It has now come to euro diagnostica's attention that it would have been preferable to have had the new expiration date stated on the alert sticker. A recall of the lot has therefore been initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616003-2017-00002
MDR Report Key6600314
Date Received2017-05-31
Date of Report2017-05-30
Date of Event2017-04-28
Date Mfgr Received2017-04-28
Device Manufacturer Date2016-10-10
Date Added to Maude2017-05-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS NINA CARLQVIST
Manufacturer StreetP. O. BOX 50117
Manufacturer CityMALMO, SKANE 20211
Manufacturer CountrySW
Manufacturer Postal20211
Manufacturer Phone640537632
Manufacturer G1EURO DIAGNOSTICA AB
Manufacturer StreetP. O. BOX 50117
Manufacturer CityMALMO, SKANE 20211
Manufacturer CountrySW
Manufacturer Postal Code20211
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDIASTAT ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL
Generic NameANA
Product CodeLKJ
Date Received2017-05-31
Lot NumberTS 3577
Device Expiration Date2017-12-31
OperatorBIOMEDICAL ENGINEER
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEURO DIAGNOSTICA AB
Manufacturer AddressP. O. BOX 50117 MALMO, SKANE 202 11 SW 202 11


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-31

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