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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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464 records meeting your search criteria returned- Product Code: LOM Product Problem: False Positive Result Report Date From: 01/1/2007

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ManufacturerBrand NameDate Report Received
ABBOTT IRELAND ALINITY I HBSAG QUALITATIVE II REAGENT K 10/12/2022
ABBOTT IRELAND ALINITY I HBSAG QUALITATIVE II CONFIRMAT 10/12/2022
ABBOTT IRELAND ALINITY I HBSAG QUALITATIVE II CONFIRMAT 09/30/2022
ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE II CONFIRMAT 09/25/2022
ABBOTT IRELAND ALINITY I HBSAG QUALITATIVE II CONFIRMAT 09/15/2022
ABBOTT IRELAND ALINITY I HBSAG QUALITATIVE II REAGENT K 09/15/2022
ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE II CONFIRMAT 09/14/2022
ABBOTT IRELAND ARCHITECT ANTI-HBS REAGENT KIT 09/09/2022
ABBOTT IRELAND ALINITY I HBSAG QUALITATIVE II REAGENT K 09/07/2022
ABBOTT IRELAND ALINITY I HBSAG CONFIRMATORY V.1 REAGENT 08/31/2022
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