Device Recall PerkinElmer

Lot Number: 646091

Clinical Chemistry and Clinical Toxicology Devices

1

No

CA, CO, NY, WA Foreign: Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands, Japan, Great Britain,

DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum

lot numbers 317113 and 317114

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Distribution to the state of : AL

PerkinElmer 226 Sample Collection Device || The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.

All software versions from 1.0 to 1.8 (current software version)

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.

Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) || Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.

Lot 181269, Expiration 8/27/03

Clinical Chemistry and Clinical Toxicology Devices

2

No

MD, NC, CA, VT, IL, MI, IL, NY, DC, MN, HI, WA, UT Nationwide. International: Belgium, Germany, Israel, UK, Canada, Hugary, Switzerland, Korea

Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube || Catalog Number: NEA104 || For in-vitro diagnostic use

Lot 181611, Expiration 8/27/03

Clinical Chemistry and Clinical Toxicology Devices

2

No

MD, NC, CA, VT, IL, MI, IL, NY, DC, MN, HI, WA, UT Nationwide. International: Belgium, Germany, Israel, UK, Canada, Hugary, Switzerland, Korea

Angiotensin I [125I] Radioimmunoassay Kit, 500 Tube || Catalog Number: NEA105 || For in-vitro diagnostic use