Siemens IMMULITE 1000 Progesterone Test Recall for Low Results
Siemens is recalling IMMULITE 1000 Progesterone tests because they may produce falsely low results, potentially leading to unnecessary progesterone supplementation.
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 (unnecessary medication) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE 1000 Progesterone test, Model LKPW1, SMN Number 10381128. The recall involves 4,780 units, with an additional 6,266 units reported as of January 13, 2020. The product was distributed globally and nationwide in the United States.
The recall is due to a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation. The affected lots are 0259 and above, with UDI 00630414985732.
Healthcare providers and laboratories using this test should stop using the affected units and contact Siemens for further instructions. Patients who have received results from these tests should consult their healthcare provider to discuss the potential impact on their treatment.
The recalled product
- Product
- IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (2)
- kit lots 0259 and above
- UDI: 00630414985732
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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