AutoDELFIA hCG kit recallZ-1238-2019 · PerkinElmer Life and Analytical Sciences, Wallac, OY · initiated Jan 10, 2019
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from PerkinElmer Life and Analytical Sciences, Wallac, OY or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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
Recall details
- Recall number
- Z-1238-2019
- Status
- Open, Classified
- Initiated by the company
- Jan 10, 2019
- Recalling firm
- PerkinElmer Life and Analytical Sciences, Wallac, OY
- Quantity
- 79 kits (none in US, all in ROW)
- Product code
- JHJ
- FDA submissions
- K862044
- Distribution
- Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
Product description
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).
Code information (models, lots, serial numbers)
Kit Lot Numbers: 664670, 666553 Pack Lot Numbers: 1066467001, 1066467002, 1066655301 UDI: (01)06438147009336(17)190430(10)664670 (01)06438147009336(17)190430(10)666553
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AutoDELFIA hCG kit B007-101Wallac Oy · Agglutination Method, Human Chorionic Gonadotropin1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 82064).
- Z-1237-2019 · Open, ClassifiedDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG…
- Z-1239-2019 · Open, ClassifiedAutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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