Siemens Healthcare Diagnostics, Inc. recalls IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number

Recalled November 2, 2016 · FDA recall Z-0319-2017 · Siemens Healthcare Diagnostics

Hazard

Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above. · FDA Class II

Units

US: 5 kits; Foreign: 372 kits

Sold at

Worldwide distribution- US (Nationwide) and countries of: United Arab Emirates, Afghanistan, Angola, Argentina, Australia, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Belarus, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Dominican Republic, Algeria, Ecuador, Egypt, Spain, France, Great Britain, Greece, Guatemala, Honduras, Hungary, India, Iraq, Italy, Jordan, Canary Islands, Kyrgyzstan, Rep. Korea (S), Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macedonia, Mexico, Malaysia, Nicaragua, Netherlands, Norway, Nepal, Peru, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, El Salvador, Syria, Turkmenistan, Tunisia, Turkey, Uruguay, Uzbekistan, Vietnam, Serbia,and South Africa.

Description

Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above.

Product

IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI 00630414963747 (OUS); IVD --- Made in UK Siemens Healthcare Diagnostics Products Ltd., Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK For in vitro diagnostic use with the IMMULITE Systems Analyzers for the qualitative detection of IgM antibodies to Cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the determination of an acute CMV infection.

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →