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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur HCY Calibrator

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 Class 2 Device Recall ADVIA Centaur HCY Calibratorsee related information
Date Initiated by FirmApril 15, 2025
Date PostedMay 27, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1822-2025
Recall Event ID 96693
510(K)NumberK013406 
Product Classification Calibrator, primary - Product Code JIS
ProductADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Code Information Siemens Material Number: 10310376. UDI Number: (01)00630414468198(10)86237A74(17)20250514, (01)00630414468198(10)44207A75(17)20250925. Kit lot numbers: 86237A74, 44207A75.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact
508-668-5000
Manufacturer Reason
for Recall		Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn Urgent Medical Device Correction (UMDC) was mailed to all US affected customers by FedEx, and an Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites with affected customers on about 04/15/2025. Customers were instructed to review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, discontinue use of and discard the affected devices, and complete and return the Effectiveness Check questionnaire. Customers were also instructed to forward the letter to those who may have received the affected devices.
Quantity in Commerce1,072 packs (2,144 units) - 156 packs US, 916 packs OUS
DistributionWorldwide - US Nationwide distribution including in the states of 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 the countries of Austria, Belgium, Croatia, Curacao,¿St¿Eus, 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, Vatikan City, Zaire.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JIS
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