Siemens Healthcare Diagnostics, Inc.: ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

Hazard

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 from the source

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. 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, Quantity: 1,072 packs (2,144 units) - 156 packs US, 916 packs OUS Lot/code info: Siemens Material Number: 10310376. UDI-DI 00630414468198 Kit lot numbers: 86237A74, 44207A75. ***Updated 5/8/26*** Additional lots 25674A77 52363A79

UPC codes

00630414468198

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.