Recall record at a glance
| Official record | Z-0366-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Report date | Nov 5, 2025 |
| Recall initiation date | Sep 22, 2025 |
| Quantity | 3318 units (169 US, 3149 OUS) |
| Location | East Walpole, MA, United States |
Official product description
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
Why the product was recalled
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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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