The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0613-2017·Announced 2016-11-23

Siemens ADVIA Centaur CA 19-9 Assay Recalled for Performance Issues

Siemens is recalling ADVIA Centaur CA 19-9 Assay kits because they do not meet performance standards on the ADVIA Centaur CP system.

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 hazard involves a performance discrepancy rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity recall.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 30,222 kits of the ADVIA Centaur CA 19-9 Assay. The recall affects kits with specific lot numbers and expiration dates, as well as all future lots until the issue is resolved. The product is distributed nationwide and in numerous foreign countries.

The recall was initiated because the CA 19-9 assay on the ADVIA Centaur CP system does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur, XP, and XPT systems as stated in the Instructions for Use. This discrepancy means the test results on the CP system may not be consistent with the other systems.

Healthcare facilities and laboratories using the ADVIA Centaur CP system should stop using the affected kits and contact Siemens for further instructions. Siemens plans to include a notecard in future lots of reagents referring customers to the communications regarding this issue.

The recalled product

Product
ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491244 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT…
Manufacturer
Siemens Healthcare Diagnostics, Inc
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
30,222

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 (5)

  • Kit lots ending in: 380 Exp Date 2016-10-21
  • 382/ 2017-01-09
  • 384 2017-02-06
  • 386 2017-03-24
  • 388 2017-05-14

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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