ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Reported: June 4, 2025 Initiated: April 15, 2025 #Z-1822-2025
Product Description
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 1,072 packs (2,144 units) - 156 packs US, 916 packs OUS
- Distribution
- Worldwide - 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.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1,072 packs (2,144 units) - 156 packs US, 916 packs OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 4, 2025. Severity: Moderate. Recall number: Z-1822-2025.
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