IMMULITE 2000 Thyroglobulin Diagnostic Kit Accuracy Issues
Siemens is recalling 7,543 kits of IMMULITE 2000 Thyroglobulin diagnostic tests due to potential accuracy and precision issues affecting diagnostic reliability.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II diagnostic accuracy recall with no reported illnesses or injuries. However, compromised diagnostic precision in a thyroglobulin monitoring test represents a risk-of-harm product without yet-reported injury, as inaccurate results could delay detection of significant clinical findings.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 7,543 kits of IMMULITE 2000 Thyroglobulin reagent kits (Catalog #L2KTY2) due to potential quality control issues affecting diagnostic accuracy.
The IMMULITE 2000 Thyroglobulin is an in vitro diagnostic test used to measure thyroglobulin levels in blood samples to monitor patients who have undergone thyroidectomy (surgical removal of the thyroid gland). Six lot numbers are affected: 431, 432, 433, 434, 435, and 436.
The issue is that control samples (quality control materials) may result outside the published acceptable ranges, and when controls are acceptable, users may observe increased imprecision (variability) in test results, particularly with low-level patient samples. This could compromise the reliability of the diagnostic results.
Healthcare providers and laboratories using affected lots should contact Siemens Healthcare Diagnostics and discontinue use of the affected kits. Healthcare professionals should review any patient results obtained with these lots.
The recalled product
- Product
- IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog #…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 7,543
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 (6)
- UDI: 00630414962252 Kit Lots: 431
- 432
- 433
- 434
- 435
- and 436.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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