Wallac Oy
TURKU Varsinais-Suomi, FI
WALLAC OY appears in FDA device records in TURKU Varsinais-Suomi, FI. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 12 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Wallac Oy carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Perkin Elmer Life Sciences Incenforcement report, recall
- PerkinElmer Life and Analytical Sciences, Wallac, OYenforcement report, recall
510(k) clearance history
FDA records hold 24 510(k) clearances for Wallac Oy between 1992 and 2014. The busiest year on record is 1993, with 3. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1993 | 3 |
| 1994 | 3 |
| 1995 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| DEN140010 | PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM | PJI | Unknown | |
| K131284 | GSP NEONATAL BIOTINIDASE KIT | NAK | Substantially Equivalent | |
| K100682 | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U | JLX | Substantially Equivalent | |
| K081922 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | JLX | Substantially Equivalent | |
| K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | JIA | Substantially Equivalent | |
| K070889 | AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 | CGZ | Substantially Equivalent | |
| K050709 | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 | GKA | Substantially Equivalent | |
| K050960 | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT | JLX | Substantially Equivalent | |
| K042425 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | JLX | Substantially Equivalent | |
| K042424 | DELFIA NEONATAL 17A-OH-PROGESTERONE KIT | JLX | Substantially Equivalent | |
| K003664 | DELFIA NEONATAL IRT KIT, MODEL A005-110 | CGZ | Substantially Equivalent | |
| K003668 | AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 | CGZ | Substantially Equivalent | |
| K993697 | DELFIA NEONATAL IRT KIT | CGZ | Substantially Equivalent | |
| DEN990008 | WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000 | NAK | Unknown | |
| K982307 | WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 | JNB | Substantially Equivalent | |
| K943416 | DELFIA NEONATAL THYROXINE KIT | CDX | Substantially Equivalent | |
| K944490 | AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT | CGI | Substantially Equivalent | |
| K940449 | DELFIA SHBG KIT | CDZ | Substantially Equivalent | |
| K935047 | AUTO DELFIA | KHO | Substantially Equivalent | |
| K932951 | DELFIA TESTTOSTERONE KIT | CDZ | Substantially Equivalent | |
| K930732 | DELFIA CORTISOL KIT | JFT | Substantially Equivalent | |
| K930484 | DELFIA(R) HGH KIT | CFL | Substantially Equivalent | |
| K924594 | DELFIA DIGOXIN KIT | KXT | Substantially Equivalent | |
| K923401 | DELFIA HTSH ULTRA KIT | JLW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043909 | 3002808498 | WALLAC OY | MUSTIONKATU 6, TURKU Varsinais-Suomi 20750 FI | 2026 | and 30 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GKAAbnormal Hemoglobin Quantitation
- QCLAcid-Sphingomyelinase (Asm) Newborn Screening Test System
- JHJAgglutination Method, Human Chorionic Gonadotropin
- PQWAlpha-D-Galactosidase A (Gla) Newborn Screening Test System
- PQUAlpha-D-Glucosidase (Gaa) Newborn Screening Test System
- PQTAlpha-L-Iduronidase (Idua) Newborn Screening Test System
- JJNApparatus, Electrophoresis, For Clinical Use
- JRGBlock, Heating
- JQPCalculator/Data Processing Module, For Clinical Use
- JITCalibrator, Secondary
- JJHClinical Sample Concentrator
- JCMControl, Hemoglobin, Abnormal
- CGZElectrode, Ion-Specific, Chloride
- JIAEnzymatic Methods, Galactose
- JJTEnzyme Controls (Assayed And Unassayed)
- KXTEnzyme Immunoassay, Digoxin
- NDREnzyme Immunoassay, Inhibin-A
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
- KHOFluorometer, For Clinical Use
- JFTFluorometric, Cortisol
- PPMGeneral Purpose Reagent
- LOKKit, Test, Alpha-Fetoprotein For Neural Tube Defects
- DOPMass Spectrometer, Clinical Use
- OHQMulti-Analyte Controls Unassayed
- QJEMuscular Dystrophy Newborn Screening Test
- JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
- JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
- JLXRadioimmunoassay, 17-Hydroxyprogesterone
- CGIRadioimmunoassay, Estriol
- CFLRadioimmunoassay, Human Growth Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- MVUReagents, Specific, Analyte
- PJISevere Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
- JRQShaker/Stirrer
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- QUESpinal Muscular Atrophy Newborn Screening Test System
- NQLSystem, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
- NAKSystem, Test, Biotinidase
- QCMß-Galactocerebrosidase (Galc) Newborn Screening Test System
- PQVß-Glucocerebrosidase (Gba) Newborn Screening Test System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2713-2026 | GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE. | Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results. | Class II | Open, Classified | |
| Z-1239-2019 | AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG). | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations. | Class II | Open, Classified | |
| Z-1238-2019 | AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG). | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations. | Class II | Open, Classified | |
| Z-1237-2019 | DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum. | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations. | Class II | Open, Classified | |
| Z-1541-2018 | Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. | Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results. | Class II | Terminated | |
| Z-1692-2018 | NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006 | 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. | Class II | Terminated | |
| Z-1220-2018 | AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212 | 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. | Class III | Terminated | |
| Z-1761-2017 | Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. | Potential for errors in patient results generated by the Specimen Gate Laboratory Software. | Class II | Terminated | |
| Z-1108-2017 | Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids. | 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. | Class II | Terminated | |
| Z-1107-2017 | Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids. | 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. | Class II | Terminated | |
| Z-0166-2016 | Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. | It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect. | Class II | Terminated | |
| Z-1116-2012 | Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. | 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. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Wallac Oy edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain