IMMULITE 1000 Progesterone recall
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
Why was IMMULITE 1000 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?
kit lots 0259 and above; UDI: 00630414985732
- Product
- IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 4780 (6266 additional as of 1/13/20)
- Distribution
- Global distribution. US Nationwide.
- Recall date
- August 28, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)