Agency classClass IIOur severity:High FDA (Devices)·Z-2290-2019·Announced 2019-08-28

Siemens IMMULITE 2000 Progesterone Test Recalled for Potential Low Results

Siemens is recalling IMMULITE 2000 Progesterone tests because some samples may produce falsely low results, potentially leading to unnecessary medication.

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 2000 Progesterone test kits. The recall affects US models L2KPW2 and L2KPW6, as well as OUS models L2KPW2(D) and L2KPW6(D). The specific SMN numbers involved are 10901873, 10901874, 10381181, and 10381170. The recall covers 6,633 units, with an additional 4,753 units reported as of January 13, 2020. The affected kits are identified by US lot numbers 510 and above, and OUS lot numbers D510 and above.

The reason for the recall is 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. This is a Class II recall, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.

The product was distributed globally and nationwide in the US. Healthcare facilities and laboratories that use these specific test kits should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions on how to return or dispose of the product. Patients who have recently received progesterone test results using these kits should consult their healthcare provider if they have concerns about their results or treatment.

The recalled product

Product: IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
incorrect-result

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 (5)

US kit lots 510 and above
OUS kit lots D510 and above
UDI: US 00630414167718
00630414167510 and OUS 00630414961972
00630414961989

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.

See all 2 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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