Wallac Oy
Active in EUDAMEDFinlandfrom SRN EUDAMED FDA SRN FI-MF-000022620 FEI 3002808498
Wallac Oy is a medical device manufacturer based in Finland, with 229 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU IVD General, Class A and IVD Annex II List B; FDA Class I) and 10 FDA recalls as of 14 Nov 2026.
- Devices
- 229
- Registrations
- EUDAMEDFDA
- FDA recalls
- 100 ongoing since 2021 (3 open in total)
Registry facts
- Registries
- EUDAMED 152
- FDA GUDID 111
- FDA 510(k) 16
- Device classes
- EU IVD General 54
- EU Class A 50
- FDA Class I 47
- EU IVD Annex II List B 41
- FDA Class II 30
- EU Class C 5
- Top EMDN categories
- FDA recalls
- Identifiers
- EUDAMED SRN FI-MF-000022620
- FDA FEI 3002808498
- DUNS 540156544
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment, FDA recalls
What Wallac Oy makes
Wallac Oy makes nucleic acid extraction and isolation kits, as well as nucleic acid sample preparation instruments, and other in vitro diagnostic devices such as the Victor2 D and DELFIA/AutoDELFIA systems. Their products include kits for extracting DNA, such as the chemagic DNA CS200 kit and the Vanadis Extract Reagent kit, and assays for various biomarkers like PlGF and hTSH.
The company's portfolio is regulated under various device classes, including Class A, Class C, Class I, Class II, IVD Annex II List B, and IVD General, and is listed in registries such as eudamed and fda_510k. Wallac Oy is based in Finland.
Catalogue
Search and filter all 229 devicesShowing 1-50 of 229
Company details
- EUDAMED SRN
- FI-MF-000022620
- FDA FEI number
- 3002808498
- DUNS number
- 540156544
- EU VAT number
- FI09371684
- EUDAMED status
- Active
- EUDAMED registered name
- Wallac Oy
- Registered address
- 6, Mustionkatu, FI-20750, Turku, Finland
- Website
- www.revvity.com
- Phone
- +3582 2678111
- PRRC contact
- Noora Mäkelä
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 26 Jun 2029
Eurofins Electric & Electronics Finland Oy 0537 1 certificate
- CR-04-1088-893-25 Active
Quality management system EU IVDR
- Issued
- 3 Sep 2026
- Expires
- 26 Jun 2029
- Reason
- Add device or group
FDA recalls
Recalls initiated per year
- 2017 6
- 2018 0
- 2019 3
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 10 Jan 2019 Z-1237-2019 Class II Open since 2019 hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Full distribution text
- 10 Jan 2019 Z-1238-2019 Class II Open since 2019 hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Full distribution text
- 10 Jan 2019 Z-1239-2019 Class II Open since 2019 hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Full distribution text
- 10 Jan 2019 Z-1237-2019 Class II Open since 2019 hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
2017
- 17 Nov 2017 Z-1541-2018 Class II Terminated Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
Full distribution text
- 2 Nov 2017 Z-1692-2018 Class II Terminated There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials.
- 25 Sep 2017 Z-1220-2018 Class III Terminated The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.
- 7 Mar 2017 Z-1761-2017 Class II Terminated Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
Full distribution text
- 5 Jan 2017 Z-1107-2017 Class II Terminated The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.
- 5 Jan 2017 Z-1108-2017 Class II Terminated The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.
- 17 Nov 2017 Z-1541-2018 Class II Terminated Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
2012
- 9 Jan 2012 Z-1116-2012 Not yet classified Terminated GSP instruments with defective washer modules may cause a false negative screening result being reported for T4, TSH and IRT. For 17-OHP, a false positive result may be generated if the failure occurs for a normal sample.
Full distribution text
- 9 Jan 2012 Z-1116-2012 Not yet classified Terminated GSP instruments with defective washer modules may cause a false negative screening result being reported for T4, TSH and IRT. For 17-OHP, a false positive result may be generated if the failure occurs for a normal sample.
FDA establishments
- Wallac, Inc. US
Frequently asked questions
How many devices does Wallac Oy have in the registry?
The registry currently lists 229 devices for Wallac Oy. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wallac Oy's devices?
Among its 50 most recently registered devices, Wallac Oy has devices listed in EUDAMED (6 devices) and FDA GUDID (46 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Wallac Oy's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Wallac Oy's devices are Class I, Class II, IVDR Class A, IVDR Class C and IVD Annex II List B. Each device page shows its own class and authorisation.
Are there FDA recall records for Wallac Oy?
FDA recall records list 10 recalls initiated by Wallac Oy, the most recent initiated on 10 Jan 2019. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Wallac Oy?
EUDAMED lists 1 certificate for Wallac Oy (quality management system) under IVDR. The most recent was issued on 3 Sep 2026.
What are the newest devices from Wallac Oy in the registry?
The most recently registered devices listed for Wallac Oy include Revvity 226 Sample Collection Device, GSP T1D 3plex kit, NeoBase Non-derivatized MSMS kit and AutoDELFIA Inhibin A kit B064-112.