IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Progesterone test kits in the United States and internationally due to a potential for falsely low progesterone results on some patient samples. A false low result could lead to unnecessary progesterone supplementation. The recall affects models L2KPW2 and L2KPW6 (and their international variants) with kit lot numbers 510 and above in the US and D510 and above internationally. Approximately 6,633 units were initially affected, with an additional 4,753 units identified as of January 13, 2020.
The source does not specify a remedy or what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
There 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.
Reason for recall: There 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. Distribution: Global distribution. US Nationwide. Quantity: 6633 (4753 additional as of 1/13/20) Lot/code info: US kit lots 510 and above; OUS kit lots D510 and above; UDI: US 00630414167718, 00630414167510 and OUS 00630414961972, 00630414961989
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.