Abbott Molecular, Inc.
FDA Regulatory Profile
Abbott Molecular, Inc. appears in FDA public data with 36 recalls — including 5 Class I (most serious) —, 19 510(k) clearances, 16 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1748-2025, Class II) was initiated on April 28, 2025. Its most recent 510(k) clearance was granted on September 25, 2025.
Summary
- Total Recalls
- 36 (5 Class I)
- 510(k) Clearances
- 19
- Inspections
- 16
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1748-2025 | Class II | Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time rev | April 28, 2025 |
| Z-1749-2025 | Class II | Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (R | April 28, 2025 |
| Z-1665-2025 | Class II | The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers inclu | March 20, 2025 |
| Z-0234-2025 | Class II | Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) RE | September 12, 2024 |
| Z-0233-2025 | Class II | Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) R | September 12, 2024 |
| Z-1602-2024 | Class II | Alinity m System, Part Number: 08N53-002 | March 20, 2024 |
| Z-1190-2024 | Class III | Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare | February 1, 2024 |
| Z-1189-2024 | Class III | In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; | February 1, 2024 |
| Z-1188-2024 | Class III | In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbo | February 1, 2024 |
| Z-0407-2024 | Class II | Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay i | October 30, 2023 |
| Z-1009-2023 | Class II | Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testi | December 9, 2022 |
| Z-0740-2023 | Class II | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 | November 22, 2022 |
| Z-0739-2023 | Class II | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 | November 22, 2022 |
| Z-1349-2023 | Class II | Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4. | November 11, 2022 |
| Z-0268-2023 | Class II | Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use | October 12, 2022 |
| Z-1679-2022 | Class II | Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1. | August 19, 2022 |
| Z-1518-2022 | Class II | The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. | July 19, 2022 |
| Z-0884-2022 | Class II | Alinity m HBV AMP Kit (US and CE) | March 4, 2022 |
| Z-0883-2022 | Class II | Alinity m HBV Application Specification File (US and CE) | March 4, 2022 |
| Z-0710-2022 | Class II | Alinity m Integrated Reaction Units (IRU) | February 11, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252102 | Alinity m HCV | September 25, 2025 |
| K243489 | Alinity m EBV (09N43-095) | July 28, 2025 |
| K243485 | Alinity m CMV | July 1, 2025 |
| K241921 | Alinity m BKV | March 24, 2025 |
| K241573 | Alinity m Resp-4-Plex | February 14, 2025 |
| K243410 | simpli-COLLECT STI Test | January 30, 2025 |
| K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) | December 6, 2024 |
| K233349 | Alinity m HSV 1 & 2 / VZV | May 3, 2024 |
| K222379 | Alinity m STI Assay | March 3, 2023 |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m E | July 15, 2022 |
| K202977 | Alinity m STI Assay | April 29, 2022 |
| K140354 | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG | May 9, 2014 |
| K131508 | VYSIS D7S486/CEP 7 FISH PROBE KIT | September 13, 2013 |
| DEN130010 | VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) | July 29, 2013 |
| K091960 | VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODE | August 29, 2011 |
| K100015 | VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMO | August 9, 2011 |
| K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 | May 28, 2010 |
| K092704 | ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 | May 28, 2010 |
| K080739 | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT | July 10, 2008 |