—#174865

Product

IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170

FDA product code: JLS — Radioimmunoassay, Progesterone
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: US kit lots 510 and above; OUS kit lots D510 and above; UDI: US 00630414167718, 00630414167510 and OUS 00630414961972, 00630414961989

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: Global distribution. US Nationwide.

Timeline

Recall initiated: 2019-07-10
Posted by FDA: 2019-08-17
Terminated: 2024-05-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174865. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.