Siemens IMMULITE 2000 Progesterone Test Kits Recalled for False Results
Siemens is recalling IMMULITE 2000 Progesterone kits because DHEA-S causes falsely elevated results, potentially affecting diagnosis.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (misdiagnosis due to false test results) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling IMMULITE 2000 Progesterone test kits (Catalog Numbers L2KPW2 and L2KPW6) due to a defect in the product's performance. The recall involves 11,963 units distributed nationwide in the United States, including Puerto Rico.
The recall is being conducted because the presence of DHEA-S (dehydroepiandrosterone sulfate) in patient samples causes falsely elevated progesterone results. This in vitro diagnostic product is used with the IMMULITE and IMMULITE 1000 Analyzers to measure progesterone in serum, which aids in the diagnosis and treatment of disorders of the ovaries or placenta.
Healthcare facilities and laboratories that have purchased these specific kits should stop using them and contact Siemens Healthcare Diagnostics for instructions on how to return the product. The affected lots are listed in the agency's recall record.
The recalled product
- Product
- IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum as an aid in the…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 11,963
Distribution
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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