Siemens IMMULITE 1000 Estradiol Test Recalled for Faslodex Interference
Siemens Healthcare Diagnostics is recalling IMMULITE 1000 Estradiol Test kits because the drug Faslodex may cause falsely elevated 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score (4) according to the rubric, as it involves a reasonable probability of adverse health consequences due to diagnostic error.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE 1000 Estradiol Test (Catalog Numbers LKE21, LKE21(D), LKE25) due to potential interference from the drug fulvestrant (Faslodex). The recall covers 9,251 units distributed worldwide, including the United States and numerous international markets.
The hazard is that the presence of fulvestrant in a patient's serum may cause the test to report falsely elevated estradiol levels. This could lead to incorrect clinical interpretations regarding hormonal sexual disorders. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare facilities and laboratories should stop using the affected test kits and contact Siemens Healthcare Diagnostics for further instructions on returns or replacements. Patients who have recently taken Faslodex and received estradiol test results should consult their healthcare provider to discuss the potential for inaccurate results.
The recalled product
- Product
- IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 9,251
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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