Siemens ADVIA Centaur HCY Calibrator packs recalled for calibrator instability
Siemens Healthcare Diagnostics is recalling certain lots of ADVIA Centaur HCY Calibrator (2 Pack) due to calibrator instability that causes increased positive bias and fails to meet reference interval specifications in the Instructions for Use.
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: This is an FDA Class II medical device recall. The source text does not report any illnesses, injuries, or failures in clinical use—only that the product does not meet specifications and may produce inaccurate results if used. This is a precautionary recall based on product specification failure rather than reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling certain lots of the ADVIA Centaur HCY Calibrator (2 Pack), Siemens Material Number 10310376. The recalled lots (86237A75 and 44207A75) do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
A total of 1,072 packs (2,144 units) have been distributed worldwide, including 156 packs to the United States and 916 packs outside the United States. The product is distributed across numerous US states (AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, VT, WI, WY) and internationally to Austria, Belgium, Croatia, Curacao, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lithuania, Nepal, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatican City, and Zaire.
Affected customers who have received this product should cease use of the affected calibrator lots and contact Siemens Healthcare Diagnostics, Inc. for further instructions.
The recalled product
- Product
- ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- calibrator-instability
- assay-reference-interval-failure
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 (2)
- (01)00630414468198(10)44207A75(17)20250925. Kit lot numbers: 86237A74
- 44207A75.
Distribution
Distributed nationwide across the United States.
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