Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FinlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of PerkinElmerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list PerkinElmer Life and Analytical Sciences, Wallac, OY with 9 device recalls. The most recent is a device recall dated Jan 10, 2019: AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hC….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 10, 2019 | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: QuantitaClass II · hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations. | Device recalls |
| Jan 10, 2019 | DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: QuantitativeClass II · hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations. | Device recalls |
| Jan 10, 2019 | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: QuantitaClass II · hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations. | Device recalls |
| Nov 17, 2017 | Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate ScrClass II · Potential errors in patient results generated by the Screening Center product that include both false negative and false | Device recalls |
| Nov 2, 2017 | NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)0643814Class II · There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a tran | Device recalls |
| Sep 25, 2017 | AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogenClass III · The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the a | Device recalls |
| Mar 7, 2017 | Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the Class II · Potential for errors in patient results generated by the Specimen Gate Laboratory Software. | Device recalls |
| Jan 5, 2017 | Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body Class II · The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditio | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
