IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
Reported: August 28, 2019 Initiated: July 10, 2019 #Z-2289-2019
Product Description
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 4780 (6266 additional as of 1/13/20)
- Distribution
- Global distribution. US Nationwide.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 4780 (6266 additional as of 1/13/20).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2019. Severity: Moderate. Recall number: Z-2289-2019.
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