ARCHITECT HAVAB-G 6L27-25 06L27-25

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for ARCHITECT HAVAB-G 6L27-25 06L27-25 manufactured by Abbott Gmbh.

Event Text Entries

[188736721] Correction/removal number= 3002809144-03/16/20-002-r. Investigation into the issue confirmed a performance shift for the architect havab-g impacted reagent lots due to the erroneous concentration for hepatitis a virus that was utilized during manufacture, which has the potential to generate falsely elevated control and patient sample results. An internal study using anti-hav negative patient samples was conducted and determined that results that fall in the range of 1. 00 - 1. 72 s/co have the potential to be falsely reactive. A product recall letter has been issued to all customers who have received the impacted lots 03429be00, 06172be00, 08073be00, and 10353be00. The product recall letter instructs the customer to immediately discontinue the use of, and destroy, any remaining inventory of the specific 4- architect havab-g reagent lots and instructs the customer to contact customer support for replacement material in the event if they were currently using or have inventory of one of the impacted lots.
Patient Sequence No: 1, Text Type: N, H10


[188736722] The account reported they were having issues with the architect havab-g reagent, lot 10353be00. The customer stated that the negative/positive quality controls passed but displayed poor recovery during correlation studies. After review, the borderline results seemed to be running higher with lot 10353be00 when compared to a different lot. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002809144-2020-00267
MDR Report Key9908088
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-17
Device Manufacturer Date2019-11-11
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCHRISTIAN LEE
Manufacturer Street100 ABBOTT PARK ROAD DEPT 09B9, BLDG CP01-3
Manufacturer CityABBOTT PARK IL 600643537
Manufacturer CountryUS
Manufacturer Postal600643537
Manufacturer Phone224668-294
Manufacturer G1ABBOTT GMBH
Manufacturer StreetMAX-PLANCK-RING 2
Manufacturer CityWIESBADEN 65205
Manufacturer CountryGM
Manufacturer Postal Code65205
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number3002809144-03/16/20-002-
Event Type3
Type of Report3

Device Details

Brand NameARCHITECT HAVAB-G
Generic NameIGG ANTI-HAV
Product CodeLOL
Date Received2020-03-31
Model Number6L27-25
Catalog Number06L27-25
Lot Number10353BE00
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT GMBH
Manufacturer AddressMAX-PLANCK-RING 2 WIESBADEN 65205 GM 65205


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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