Reported Aug 28, 2019 · Terminated
IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- IMMULITE 2000 Progesterone
- Models USL2KPW2
- L2KPW6 and OUS
L2KPW2(D)L2KPW6(D)
- SMN Numbers US
1090187310901874 and OUS 1038118110381170
- Lot codes and dates
US kit lots 510 and aboveOUS kit lots D510 and above
- UDI
US 0063041416771800630414167510 and OUS 0063041496197200630414961989
- Amount recalled
- 6633 (4753 additional as of 1/13/20)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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