IMMULITE 2000 Thyroglobulin test kits recalled for reduced analytical sensitivity
Siemens is recalling 717 IMMULITE 2000 Thyroglobulin test kits because they may not accurately measure thyroglobulin levels. Inaccurate results could affect monitoring of thyroid cancer patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving analytical performance issues with no reported illnesses or injuries. The hazard—reduced sensitivity and precision in thyroglobulin testing—represents a risk of inaccurate patient monitoring but has not resulted in documented patient harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 717 IMMULITE 2000 Thyroglobulin test kits distributed nationwide and internationally. The affected kit lots are D431, D433, D434, D435, and D436. These are in vitro diagnostic kits used with IMMULITE 2000 and IMMULITE 2000 XPi analyzer systems for quantitative measurement of thyroglobulin.
The test kits may not meet the analytical performance specifications claimed in the Instructions For Use. Quality control measurements at control level one may fall outside the published acceptable ranges. Additionally, when quality control results appear acceptable, the test may show increased imprecision when measuring low-level patient samples. These issues could result in inaccurate thyroglobulin measurements.
Thyroglobulin testing is used to monitor patients who have undergone thyroidectomy (thyroid removal), typically as part of thyroid cancer follow-up care. Inaccurate test results could compromise the accuracy of patient monitoring.
Healthcare providers and testing laboratories using the affected lots should discontinue use and contact Siemens for replacement kit information. Patients who received test results from affected lots may wish to consult with their healthcare provider about the need for retesting.
The recalled product
- Product
- IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroi
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- analytical-sensitivity
- analytical-precision
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI: 00630414972084 Kit Lots: D431
- D433
- D434
- D435
- and D436
Distribution
Distributed nationwide across the United States.
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