The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1486-2018·Announced 2018-05-02

Siemens ADVIA Centaur CA 125II Assay Recalled for Over-Recovery

Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 125II Assay kits because some patient samples may exhibit over-recovery outside the provided data.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity recall involving potential accuracy issues.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur CA 125II Assay. The affected products include Cat No. 09427226 (SMN 10310443) and Cat No. 01678114 (SMN 10315696). The recall covers 13,257 kits of the 1-pack/100 tests and 9,930 kits of the 5-pack/500 tests.

The recall was initiated because, upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use. This issue may affect the accuracy of test results.

The affected products were distributed in the United States and numerous international countries. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.

The recalled product

Product
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
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 (19)

  • SMN 10310443 (1-pack/100 tests): Lot 71804174
  • Exp 2018-Apr-27
  • UDI (01)00630414461298(10)71804174(17)20180427 Lot 73838174
  • UDI (01)00630414461298(10)73838174(17)20180427 Lot 88601174
  • UDI (01)00630414461298(10)88601174(17)20180427 Lot 94549174
  • UDI (01)00630414461298(10)94549174(17)20180427 Lot 23904176
  • Exp 2018-Aug-30
  • UDI (01)00630414461298(10)23904176(17)20180830 Lot 24439176
  • UDI (01)00630414461298(10)24439176(17)20180830 Lot 31842176
  • UDI (01)00630414461298(10)31842176(17)20180830 Lot 42051176
  • UDI (01)00630414461298(10)42051176(17)20180830 Lot 54008176
  • UDI (01)00630414461304(10)71229174(17)20180427 Lot 73455174
  • UDI (01)00630414461304(10)73455174(17)20180427 Lot 84113174
  • UDI (01)00630414461304(10)84113174(17)20180427 Lot 91568174
  • UDI (01)00630414461304(10)91568174(17)20180427 Lot 23903176
  • UDI (01)00630414461304(10)23903176(17)20180830 Lot 24944176
  • UDI (01)00630414461304(10)24944176(17)20180830 Lot 41442176
  • UDI (01)00630414461304(10)41442176(17)20180830 Lot 46735176
  • UDI (01)00630414461304(10)46735176(17)20180830

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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