CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report
Immulite 1000 Progesterone recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling Immulite 1000 Progesterone, distributed nationwide in the US. The recall was initiated on 10 Jul 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2289-2019
- FDA event ID
- 83349
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jul 2019
- FDA classified
- 17 Aug 2019
- Reported
- 28 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 10 Jul 2019 | Recall initiated by company | |
| 17 Aug 2019 | Classified by FDA | +38 days |
| 28 Aug 2019 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
Where it was distributed
Global distribution. US Nationwide.
Questions about this recall
Why was it 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 lots are affected?
kit lots 0259 and above; UDI: 00630414985732
Where was it sold?
Global distribution. US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 83349| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Immulite 2000 Progesterone recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
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