FDA Medical Device Recalls (openFDA)
PerkinElmer Life and Analytical Sciences, Wallac, OY: 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.
- Recall number
- Z-1237-2019
- Recalling firm
- PerkinElmer Life and Analytical Sciences, Wallac, OY
- Product
- 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.
- Status
- Open, Classified
- Initiated
- 2019-01-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
- Root cause
- Nonconforming Material/Component
- Action
- Perkin Elmer initiated notification on January 10, 2018. The Recall Letter delivered to the end customer by email facilitated through the PerkinElmer Technical Support Group. PerkinElmer requires customers to: Inspect DELFIA / AutoDELFIA hCG kit inventory for the affected lots. Review your QC follow-up of the AutoDELFIA hCG assay for potential decrease in the control concentrations. If the control values are within your established acceptance range it is safe to report the results To avoid unnecessary repeat testing of samples, if the control values are out of the acceptance range discontinue use of the DELFIA / AutoDELFIA hCG kit lot and dispose the remaining kits of the lot. Complete the Response Form with the quantity of affected DELFIA / AutoDELFIA hCG kits you have disposed from your inventory
- Quantity
- 31 kits (10 in US, 21 in ROW)
- Distribution
- Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
- Lot, serial or model codes
- Kit Lot Numbers: 664891, 666471, 666604 Pack Lot Numbers: 1066489101, 1066647101,1066660401 UDI: (01)06438147009176(17)190430(10)664891 (01)06438147009176(17)190430(10)666471 (01)06438147009176(17)190430(10)666604
- 510(k) numbers
- ["K862044"]
- PMA numbers
- not on file
- Product code
- JHJ
- Firm FEI
- 3002808498
- Firm city
- Turku
- Firm state
- not on file
- Firm country
- Finland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28