FDA-Device2025-11-05Class IIPROCESSING DEFECT
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
Hazard
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of AL, CA, DC, FL, ID, IN, LA, MD, NC, NJ, NY, PA, SC and the countries of Argentina, Australia, Bolivia, Bosnia Herzeg, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Iran, Israel, Italy, Kosovo, Kuwait, Latvia, Lebanon, Macedonia, Mexico, Nepal, Netherlands, P.R. China, Pakistan, Palestinian Ter, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, South Africa, Spain, Taiwan, Tunisia, Turkey, Turkmenistan, U.A.E., Ukraine, Uruguay, Uzbekistan.
Affected count
3318 units (169 US, 3149 OUS)
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0366-2026Want us to check the next one for you?
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