The Recall Desk
ModerateFDA (Devices)·Z-0320-2017·Announced 2016-11-02

Siemens CMV IgM Assay Recalled for Increased Imprecision

Siemens Healthcare Diagnostics is recalling IMMULITE 2000 CMV IgM Assay kits due to reported increased imprecision and high coefficient of variation results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, only increased imprecision in test results. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported harm.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling specific lots of the IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay. The recall involves 326 kits distributed in the United States and 9,633 kits distributed internationally. The affected products are used for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma.

The recall was initiated after multiple customers reported an increase in imprecision with the assay, resulting in high percentage coefficient of variations (% CVs) for some patients. This issue was observed starting with reagent lots 259 and above. The affected kit lots include D255 through D264 and D266 for the US catalog number L2KCM2(D), and lots 255 through 264, 266, and 267 for the international catalog number L2KCM2.

Healthcare facilities and laboratories using these specific lots should stop using the affected kits and contact Siemens Healthcare Diagnostics for further instructions. The recall covers worldwide distribution, including the United States and numerous countries across Europe, Asia, the Americas, and the Middle East.

The recalled product

Product
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 Diagno
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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