Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catal

Is my product affected?

IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD --- Siemens Healthcare Diagnostics Products Ltd., Ll

• UPC 00630414985725
• UPC 00630414961163

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

What happened

Siemens Healthcare Diagnostics recalled IMMULITE 2000/IMMULITE 2000XPi Systems CMV IgM Assay kits due to increased imprecision affecting test results. The issue involved high variability in results with some patients beginning with reagent lots 259 and above. A total of 326 kits were distributed in the US and 9,633 kits were distributed internationally across multiple countries.

The affected kits include those with catalog numbers L2KCM2(D) and L2KCM2 in lot numbers D255-D264, D266 and 255-267. The source document does not specify a remedy or what affected consumers should do in response to 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: 326 kits; Foreign: 9633 kits Lot/code info: UDI 00630414985725/Catalog # L2KCM2(D): Kit lots D255, D256, D257, D258, D259, D260, D261, D262, D263, D264, D266; UDI 00630414961163/Catalog # L2KCM2: Kit lots 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 266, 267

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• 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); I2016-08-30
• GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.2016-08-31
• enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code 952040-EG 6844097. The VITROS 5,1 FS Chemistry System with enGen Laboratory Aut2016-09-07
• LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the e2016-09-13
• Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 20162016-09-14

All FDA (Device enforcement) recalls