PerkinElmer Life and Analytical Sciences, Wallac, OY: Medical Device Recall in 2019 - (Recall #: Z-1238-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: January 10, 2019

Date Posted: May 8, 2019

Recall Number: Z-1238-2019

Event ID: 82064

Reason for Recall:

hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

Status: Ongoing

Product Quantity: 79 kits (none in US, all in ROW)

Code Information:

Kit Lot Numbers: 664670, 666553 Pack Lot Numbers: 1066467001, 1066467002, 1066655301 UDI: (01)06438147009336(17)190430(10)664670 (01)06438147009336(17)190430(10)666553

Distribution Pattern:

Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.

Voluntary or Mandated:

Voluntary: Firm initiated