MAUDE Adverse Event Report: Grifols Diagnostic Solutions Inc Procleix Ultrio Elite Assay; HIV/HCV/HBV Device

Catalog Number	9051171
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Transfusion Reaction (4596)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer (b)(6) reported on 10aug2026 discrepant hbv results with a donor sample that tested nonrepeat reactive on the ultrio elite screening assay on (b)(6) 2026 and (b)(6) 2026.A fresh sample was initially taken from the donor on (b)(6) 2026 that tested reactive on ultrio elite (3x), hbv discriminatory and serology (anti-hbs and anti-hbc).Hbsag, hbe ag and anti- hbe were negative.A look back at the donor results showed that a sample drawn from the same donor on 12dec2025 was negative for ultrio elite and serology (hbs ag).The archived sample was retested on (b)(6) 2026 with non repeat reactive results for ultrio elite, nonreactive hbv discriminatory results and positive results for anti-hbc (negative anti-hbs).A fresh draw from the donor was taken on (b)(6) 2026 and tested on ultrio elite in duplicate resulting in nonrepeat reactive results.The first sample tested positive at 17 iu/ml on qhbv pcr (abbott alinity) but negative with the second sample tested.The status of the blood donation drawn on (b)(6) 2025 and (b)(6) 2026 is pending.Summary of customer testing: (b)(6) 2025: initial fresh draw ultrio elite ml 710006 s/co, nonreactive serology (abbott alinity) hbsag nonreactive.(b)(6) 2026: fresh draw ultrio elite ml 710333 s/co, reactive (3x) hbv discriminatory, reactive serology (abbott alinity) hbsag nonreactive anit-hbs (10 iu/ml) reactive anti-hbc (6.5 s/co) reactive hbe ag nonreactive anti-hbe nonreactive.(b)(6) 2026: archived sample from (b)(6) 2025 ultrio elite ml 710333 s/co, reactive s/co, nonreactive hbv discriminatory, nonreactive.Serology (abbott alinity) hbsag nonreactive anit-hbs (8.28 iu/ml) nonreactive anti-hbc (6.29 s/co) reactive hbe ag nonreactive anti-hbe nonreactive.(b)(6) 2025: fresh draw ultrio elite ml 710333 sample 1: s/co, reactive qhbv pcr (abbott alinity) 17 iu/ml, reactive.Sample 2: s/co, reactive s/co, nonreactive (2x) qhbv pcr (abbott alinity) nonreactive.An investigation is ongoing for the discrepant hbv results.Remaining sample from the donor is pending availability for investigational testing.No related quality events were found for the lots/batches of product and the products met all release criteria.A previous events search did not indicate a trend for hbv sensitivity issues with procleix ultrio elite ml 710006 or ml 710333.

• Brand Name: Procleix Ultrio Elite Assay
• Common Device Name: HIV/HCV/HBV Device
• Manufacturer (Section D): Grifols Diagnostic Solutions Inc; 10808 willow court; san diego CA 92127
• Manufacturer Contact: sumit khurana ; 10808 willow court; san diego, CA 92127 ; +1(858)524-0293
• MDR Report Key: 50777945
• Report Number: 2032600-2026-00004
• Device Sequence Number: 10679916
• Product Code: QHO
• UDI-Device Identifier: 00859882007672
• UDI-Public: 00859882007672
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: BL 125652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 9051171
• Device Lot Number: 710333
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 08/15/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown