Z-1238-2019Class II

AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)

Name: Z-1238-2019 AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
Creator: PerkinElmer Life and Analytical Sciences, Wallac, OY
Published: 2019-01-10
License: https://open.fda.gov/license/

Wallac Oy / initiated 2019-01-10 / Open, Classified / root cause: manufacturing process

FDA source

PerkinElmer Life and Analytical Sciences, Wallac, OY began a recall of AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of... on 2019-01-10. FDA classified it as Class II and gives the reason as "hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1238-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-01-10
Posted: 2019-04-27
Recalling firm: Wallac Oy
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).
Product code: JHJ Agglutination Method, Human Chorionic Gonadotropin
Reason for recall: hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Root cause tag: manufacturing process
FDA 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 in commerce: 79 kits (none in US, all in ROW)
Distribution: Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
Product codes and lots: Kit Lot Numbers: 664670, 666553 Pack Lot Numbers: 1066467001, 1066467002, 1066655301 UDI: (01)06438147009336(17)190430(10)664670 (01)06438147009336(17)190430(10)666553

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1238-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1237-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-08	2019-04-26
Z-1238-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-08	2019-04-26
Z-1239-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-08	2019-04-26

Product code JHJ

K862044Class IIDelfia (Tm) Hcg KitLkb Instruments, Inc. / cleared 1986-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)