ABBOTT GMBH ALINITY S HIV AG/AB COMBO REAGENT KIT; HUMAN IMMUNODEFICIENCY VIRUS TYPES 1 AND 2 AG, AB (P24) AND SYNTHETIC PEPTIDES
|
Back to Search Results |
|
Catalog Number 06P01-55 |
Device Problem
False Positive Result (1227)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/15/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 06p01-55 that has a similar product distributed in the us, list number 06p01-60.
|
|
Event Description
|
The customer reported an increase in false repeat reactive alinity s hiv ag/ab combo results on multiple patients.Results provided: date (b)(6)2021; id (b)(6); initial (b)(6); repeat (b)(6); (s/co) (b)(6).No impact to patient management was reported.
|
|
Manufacturer Narrative
|
Section b5 additional patient data provided: (b)(6) 2021 1.2.41, 1.55, 1.52.4.1.52, 1.11, 1.19.10.3.11, 1.33, 1.28.14.1.04, 1.13, 1.22.(b)(6) 2021 1.2.22, 1.00, 0.99.
|
|
Event Description
|
The customer reported an increase in false repeat reactive alinity s hiv ag/ab combo results on multiple patients.Results provided: date id initial, repeat, (s/co).(b)(6) 2021.1.1.13, 1.43, 1.39.2.1.11, 1.61, 1.47.4.1.04, 1.54, 1.52.5.1.26, 2.04, 1.9.6.1.2, 1.9, 1.88.7.1.3, 2.41, 2.51.(b)(6) 2021 1.1.41, 1.45, 1.46.2.1.09, 1.09, 1.08.3.1.25, 1.61, 1.59.4.0.9, 1.17, 1.17.6.0.86, 1.07, 1.1.(b)(6) 2021 1.1.22, 1.74, 1.75.2.1.48, 1.55, 1.53.3.1.12, 1.17, 1.17.(b)(6) 2021 1.5.14, 4.77, 5.04.(b)(6) 2021 1.2.2, 1.73, 1.86.2.1.08, 1.06, 1.23.(b)(6) 2021 1.2.41, 1.55, 1.52.4.1.52, 1.11, 1.19.10.3.11, 1.33, 1.28.14.1.04, 1.13, 1.22.(b)(6) 2021 1.2.22, 1.00, 0.99.No impact to patient management was reported.
|
|
Manufacturer Narrative
|
After further evaluation, the suspect medical device was changed to alinity s, list 6p16 (irving, tx as manufacturing site) and submitted under manufacturer report numbers 1628664-2022-00007-00 and 1628664-2022-00005-00.All further information will be documented under mdr numbers 1628664-2022-00007-00 and 1628664-2022-00005-00.Section g1 updated contact information.
|
|
Event Description
|
The customer reported an increase in false repeat reactive alinity s hiv ag/ab combo results on multiple patients.Results provided: date id initial repeat (s/co) (b)(6) 2021.1.1.13 1.43 1.39, 2.1.11 1.61 1.47, 4.1.04 1.54 1.52, 5.1.26 2.04 1.9, 6.1.2 1.9 1.88, 7.1.3 2.41 2.5.1 (b)(6) 2021 1.1.41 1.45 1.46, 2.1.09 1.09 1.08, 3.1.25 1.61 1.59, 4.0.9 1.17 1.17, 6.0.86 1.07 1.1.(b)(6) 2021 1.1.22 1.74 1.75, 2.1.48 1.55 1.53, 3.1.12 1.17 1.17.(b)(6) 2021 1.5.14 4.77 5.04, 01.12.2021 1.2.2 1.73 1.86, 2.1.08 1.06 1.23.(b)(6) 2021 1.2.41 1.55 1.52, 4.1.52 1.11 1.19, 10.3.11 1.33 1.28, 14.1.04 1.13 1.22.(b)(6) 2021 1.2.22 1.00 0.99 no impact to patient management was reported.
|
|
Search Alerts/Recalls
|
|
|