Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Reported: June 4, 2025 Initiated: April 15, 2025 #Z-1821-2025
Product Description
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
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
- 2,212 packs (4,424 units) - 448 packs US, 1,764 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? ▼
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 2,212 packs (4,424 units) - 448 packs US, 1,764 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-1821-2025.
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