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IMMULITE 2000 Systems PRG Progesterone recallZ-2290-2019 · Siemens Healthcare Diagnostics, Inc. · initiated Jul 10, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-2290-2019
Status
Terminated
Initiated by the company
Jul 10, 2019
Posted by the FDA
Aug 17, 2019
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
6633 (4753 additional as of 1/13/20)
Product code
JLS
Distribution
Global distribution. US Nationwide.

Product description

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

Code information (models, lots, serial numbers)

US kit lots 510 and above; OUS kit lots D510 and above; UDI: US 00630414167718, 00630414167510 and OUS 00630414961972, 00630414961989

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 83349).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page