IMMULITE 2000 Progesterone recall
IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
Why was IMMULITE 2000 Progesterone recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
US kit lots 510 and above; OUS kit lots D510 and above; UDI: US 00630414167718, 00630414167510 and OUS 00630414961972, 00630414961989
- Product
- IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 6633 (4753 additional as of 1/13/20)
- Distribution
- Global distribution. US Nationwide.
- Recall date
- August 28, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)