Siemens Healthcare Diagnostics, Inc.: IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identi

Is my product affected?

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); I

• UPC 00630414985718
• UPC 00630414963747

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics is recalling IMMULITE/IMMULITE 1000 Systems CMM CMV IgM Assay kits due to reported increases in imprecision affecting some patients, with high coefficient of variation (CV) percentages occurring starting with reagent lots 259 and above. The affected products were distributed worldwide, including throughout the United States and 47 other countries, with 5 kits distributed in the US and 372 kits distributed internationally. The specific affected lots include kit lot D0330 under catalog number LKCM1(D) and kit lots 0330 and 0331 under catalog number LKCM1.

The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: 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, Ita Quantity: US: 5 kits; Foreign: 372 kits Lot/code info: UDI 00630414985718/Catalog # LKCM1(D): Kit lot D0330; UDI 00630414963747/Catalog # LKCM1: Kit lots 0330, 0331

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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