Siemens IMMULITE 2000 Estradiol Test Recalled Due to Faslodex Interference
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Estradiol Test kits because the drug fulvestrant (Faslodex) may cause falsely elevated estradiol results.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential diagnostic error (falsely elevated results) due to drug interference, which is a moderate risk of adverse health consequences if relied upon for treatment decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE 2000 Estradiol Test Code E2 (Catalog Numbers L2KE22, L2KE22 (D), L2KE26, L2KE26 (D); SMNs 10381178, 10702833, 10381177, 10702834). The recall involves 9,334 units distributed worldwide, including the United States and numerous international locations.
The recall is being conducted because the drug fulvestrant (Faslodex) may cause falsely elevated estradiol results when used with this test. The test is intended for in vitro diagnostic use on IMMULITE 2000 systems analyzers for the quantitative measurement of estradiol in serum, serving as an aid in the diagnosis and treatment of various sexual disorders.
Healthcare providers and laboratories using this product should be aware of the potential for inaccurate results in patients taking fulvestrant. No specific instructions for consumer action are provided in the source text, as this is a medical device used in professional diagnostic settings.
The recalled product
- Product
- IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use the IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 9,334
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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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