Device Recall Access Immunoassay Systems

Access 2 Immunoassay Systems Part Number 81600N software versions 20., 2.1, and 2.2. Access Immunoassay Systems Chlamydia Reagent Kit Part Number 34401.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and Canada

Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.

Lot # 913348

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- USA (nationwide) including the states of CA, CT, MA, NC, NM and TX and the country of Canada.

Access¿ Immunoassay Systems || UNCONJUGATED ESTRIOL || Part # 33570 || The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.

Lot Number: 917074, 008534  Expiration Date: 917074 (12/31/10), 008534 (2/28/11)

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution-USA (nationwide) and the country of Canada.

Access¿ Immunoassay Systems Total T4 Calibrators, || Part Number: 33805, || Subsequent Product Code: JIS || The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems.

019818, 021654, 024072

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Egypt, El Salvador, Ethiopia, France, Germany, Greece, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Lebanon, Libyan Arab Jamahiriya, Liechtenstein, Macao, Malaysia, Mexico, Netherlands, Nigeria, Pakistan, Panama, Philippines, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.

Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. || The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.

Part # 81600N, 386220, A12900, A69186; All Serial Numbers

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution: USA (nationwide) and countries of: Aurstria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Djibouti, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Access 2 Immunoassay System; P/N 107405S 2/12 || The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.