FDA Device recall Z-1238-2019
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantita…
- FDA Device
- Class II
- ongoing
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class II recall of AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantita… by Perkinelmer Life And Analytical Sciences Wallac Oy, citing hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1238-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-01-10 |
| Published | 2019-05-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Perkinelmer Life And Analytical Sciences Wallac Oy |
| Distribution | US |
Product
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).
Reason
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Identifiers
| code_info | Kit Lot Numbers: 664670, 666553 Pack Lot Numbers: 1066467001, 1066467002, 1066655301 UDI: (01)06438147009336(17)19043…Kit Lot Numbers: 664670, 666553 Pack Lot Numbers: 1066467001, 1066467002, 1066655301 UDI: (01)06438147009336(17)190430(10)664670 (01)06438147009336(17)190430(10)666553 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1238-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.