Class 2 Device Recall IMMULITE 1000 Progesterone

• Date Initiated by Firm: July 10, 2019
• Date Posted: August 17, 2019
• Recall Status: Open, Classified
• Recall Number: Z-2289-2019
• Recall Event ID: 83349
• Product Classification: Radioimmunoassay, progesterone - Product Code JLS
• Product: IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
• Code Information: kit lots 0259 and above; UDI: 00630414985732
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: Siemens Customer Care Center; 312-275-7795
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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
• Quantity in Commerce: 4780 (6266 additional as of 1/13/20)
• Distribution: Global distribution. US Nationwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.