The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0860-2015·Announced 2014-12-31

Siemens ADVIA Centaur XP Immunoassay System Recalled for Tubing Crack Risk

Siemens Healthcare Diagnostics is recalling 10,515 ADVIA Centaur XP Immunoassay Systems because a slight crack may occur in the tubing at the reservoir connector assembly due to mechanical stress.

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, but the source text describes a mechanical defect (slight tubing crack) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 10,515 units of the ADVIA Centaur XP Immunoassay System, including refurbished units. These devices are used in professional laboratory settings for in vitro diagnostic tests.

The recall is being conducted because a slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress. The affected units were distributed nationwide, including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, MD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

The affected product codes are 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, and 10471899. Laboratory professionals should contact Siemens Healthcare Diagnostics for further instructions regarding the recall.

The recalled product

Product
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
10,515

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 (16)

  • Product Codes: 10285219
  • 10316507
  • 10317207
  • 10317284
  • 10319668
  • 10320757
  • 10323213
  • 10324519
  • 10327135
  • 10327836
  • 10328940
  • 10329339
  • 10336292
  • 10338631
  • 10364455
  • 10388696 and 10471899.

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

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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