Health product recall

Ultra-sensitive Estradiol RIA (2019-03-26)

Starting date:
March 26, 2019
Posting date:
April 18, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69630



Last updated: 2019-04-18

Affected Products

Ultra-sensitive Estradiol RIA

Reason

Due to low binding of Ultra-sensitive Estradiol RIA kit (PN DSL-4800) lot 190225C the precision of the results can be affected and patient sample concentrations can be falsely elevated or falsely low.

Affected products

Ultra-sensitive Estradiol RIA

Lot or serial number

190225C

Model or catalog number

DSL-4800

Companies
Manufacturer

IMMUNOTECH s.r.o.

Radiová 1

Praha 10

10227

CZECH REPUBLIC