Recall Z-0320-2017 ยท LKQ Antibody Igm,If, Cytomegalovirus Virus
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/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD --- Siemens Healthcare Diagnostics Products Ltd., Llanberis, Gwynedd, LL55 4EL UK For in vitro diagnostic use with IMMULITE 2000 analyzers for the q
| Date | Aug 30, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | The firm, Siemens, issued an "Urgent Medical Device Recall" Letter (IMC16-22.A.US, dated 8/30/2016) in the US and an "Urgent Field Safety Notice" (IMC16-22.A.OUS, dated August 2016) Outside the US (OUS) starting on 8/30/2016 The notices instructed customers to discontinue use of and discard the affected kit lots listed in the customer notice; review your inventory of the products to determine your laboratory's replacement needs; review the UMDR and or the UFSN with their Medical Director, In the US, the method of distribution is FedEx and Outside the US the distribution is determined at the c |
| Quantity | US: 326 kits; Foreign: 9633 kits |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100433 | IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, Siemens Healthcare Diagnostics, May 13, 2010 |