PMA · Approved
Recalled · Class II · 2023Alinity m HCV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Molecular, Inc. · MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Approved on Mar 23, 2020 through premarket approval, which rests on the device’s own clinical evidence after a 175-day review. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Mar 23, 2020
- Review
- 175 days
- Class
- Class II
- Product code
- MZP
- Recalls
- 5
1 later device descends from it, 1 citing it directly.
- This deviceP190025 Alinity m HCVAbbott Molecular, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK252102 Alinity m HCVAbbott Molecular, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252102Alinity m HCVAbbott Molecular, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P190025 | Alinity m HCV | Abbott Molecular, Inc. | 2020 | — |
| +1 | K252102 | Alinity m HCV | Abbott Molecular, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MZP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MZP device
- #1 K252484 cobas HCVscore 10.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252102 | Alinity m HCV | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2023 | Class II | Z-0407-2024 | Other | Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit. |
| Dec 9, 2022 | Class II | Z-1009-2023 | Under Investigation by firm | The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file)… |
| Nov 11, 2022 | Class II | Z-1349-2023 | Under Investigation by firm | The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a… |
| Jul 19, 2022 | Class II | Z-1518-2022 | Nonconforming Material/Component | Incorrect optical calibration |
| Dec 6, 2021 | Class II | Z-0463-2022 | Software design | There is an issue with the installation of updated camera firmware on the system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K252102 (Abbott Molecular, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MZP devicesMZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MZP
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MZP
Too few MZP 510(k)s in any year since 2007 to give a median.
Recalls per year · MZP
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MZP
12in 2025
MAUDE reports naming product code MZP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | — | 1 | 0 |
| 2008 | 12 | — | 0 | 6 |
| 2009 | 11 | — | 0 | 12 |
| 2010 | 19 | — | 0 | 11 |
| 2011 | 20 | — | 2 | 44 |
| 2012 | 17 | — | 0 | 26 |
| 2013 | 24 | — | 0 | 36 |
| 2014 | 12 | — | 0 | 13 |
| 2015 | 12 | — | 0 | 1 |
| 2016 | 21 | — | 0 | 12 |
| 2017 | 15 | — | 0 | 5 |
| 2018 | 30 | — | 0 | 4 |
| 2019 | 35 | — | 0 | 5 |
| 2020 | 18 | — | 0 | 1 |
| 2021 | 8 | — | 4 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P190025 · printed Nov 4, 2026
Cite this page
510(k) Report. “P190025: Alinity m HCV.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P190025
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026