Siemens IMMULITE Progesterone Test Kits Recalled for DHEA-S Interference
Siemens is recalling IMMULITE Progesterone test 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. The hazard involves diagnostic inaccuracy (falsely elevated results) which poses a risk of harm through misdiagnosis, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 9,076 units of IMMULITE/IMMULITE 1000 Progesterone test kits (Catalog Number LKPW1). The affected lots are 0245, 0246, 0247, 0248, and 0249. These kits are used for in vitro diagnostic testing to measure progesterone levels in serum.
The recall was initiated because the presence of DHEA-S (dehydroepiandrosterone sulfate) in the sample causes falsely elevated progesterone results. This interference can lead to inaccurate diagnostic information regarding disorders of the ovaries or placenta.
The affected products were distributed nationwide in the United States, including Puerto Rico. Users of these kits should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions on returning the product or obtaining replacements.
The recalled product
- Product
- IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 9,076
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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