Siemens Healthcare Diagnostics, Inc. IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
kit lots 0259 and above, UDI: 00630414985732
Products Sold
kit lots 0259 and above; UDI: 00630414985732
Siemens Healthcare Diagnostics, Inc. is recalling IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 due to There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consid. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Urgent Medical Device Correction notification letters were sent to customers beginning 7/10/19. Actions to be Taken by the Customer 1) Please review this letter with your Medical Director. 2) If interference is suspected, follow your established internal procedures to investigate the interference. 3) Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 4) If you have received any complaints of illness or adverse events associated with the products, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. The firm reports that a removal at this time is not necessary because: "Siemens does not intend to remove the product as based on available data, it is estimated the occurrence is <1%. Siemens recommends that the laboratories follow their internal procedures if interference is suspected. A Follow up Urgent Medical Device Correction dated 1/13/20 was sent to customers. Actions to be Taken by the Customer Note: Interference will not be detected by quality control and the presence of the interference may not be readily identifiable. Follow your established internal procedures to determine if additional testing is needed to identify samples with suspected interference and to determine if the patient sample result is accurate. A potential approach to identify interference is to dilute the sample. In-house studies have shown that a 1:5 dilution of the sample is effective in diluting out the potential interferant. Please note that for samples with an undiluted result of d 1 ng/mL, greater variability could potentially be observed after dilution due to assay precision in this region. Instructions Please review this letter with your Medical Director. Complete and return
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026