FDA recall Z-1239-2019

Product

AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2019-01-10

Report date

2019-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Turku, N/A, Finland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1239-2019