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IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) recallZ-0524-2009 · Siemens Medical Solutions Diagnostics · initiated Jul 21, 2008

Terminated All recalls posted in December 2008

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 Medical Solutions Diagnostics 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

Siemens Healthcare Diagnostics has confirmed a long-standing high bias with LKPG 1, 5. (The bias is approximately 25% at 10 - 20 ng/mL as opposed to approximately 3% at 1-3 ng/mL - for more detail see the bias plot that is included with this notice.).

FDA root cause category: Other

What the company is doing

Siemens initiated the recall on 07/22/2008 by forwarding A Customer Bulletin by fax or mail to all affected Siemens Healthcare Diagnostic Branches for communication with the affected customers. The Customer Bulletin informed their customers that the firm is conducting a field correction and requested that they discontinue using any IMMULITE/IMMULITE 1000 kit lot prior to LKPG 1,5 330. They were also instructed to complete attached Completion Notification Form and return to their local Siemens Healthcare office or distributor as soon as possible. The were informed that replacement kits will be provided once the completed forms have been received. The Customer Bulletin recommend their customer discuss the content of the letter with their laboratory director regarding the need to review previous test results, conduct patient follow up, and/or repeat testing. The bias should not impact the in-vitro fertilization clinical application because the average change for samples within the range of 1-3 ng/mL is less than 5%. Although there is a greater degree of shift at higher concentrations, the clinical impact is considered to be relatively low when using the test for the diagnosis of ectopic pregnancy and luteal phase defects because in these situations, the progesterone result should always be considered in conjunction with other tests. PROGESTERONE DETERMINATIONS USED IN THE DIAGNOSIS OF PLACENTAL INSUFFICIENCIES OR FOR MONITORING PROGESTERONE THERAPY MAY HAVE BEEN AFFECTED BY THE HIGH BIAS. The letter also indicated SIEMENS IS INTRODUCING A RE-CALIBRATED IMMULITE PROGESTERONE KIT BEGINNING WITH KIT LOT LKPG1, 5 300, WHICH WILL BEGIN ROUTINELY SHIPPING AUGUST 15 TH. AT THAT TIME, KITS WITH THE PREVIOUS CALIBRATION WILL ONLY BE AVAILABLE UPON REQUEST AND AVAILABILITY OF INVENTORY FOR CUSTOMERS WHO STILL NEED TO PERFORM BASELINING STUDIES. An Important Notice, which is reproduced at the end of this notice below, will be included with the recalibrated kits

Recall details

Recall number
Z-0524-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 21, 2008
Posted by the FDA
Dec 23, 2008
Recalling firm
Siemens Medical Solutions Diagnostics
Quantity
12,908
Product code
JLS
FDA submissions
K944211
Distribution
Worldwide Distribution --- including USA and countries of Argentina, Aruba, Australia, Austria, Bangladesh, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Mexico, Netherlands, Nicaragua, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Republic of Panama, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Arab Emirates (UAE), United Kingdom, Uruguay, and Venezuela.

Product description

IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.

Code information (models, lots, serial numbers)

Lot Numbers: 318, 319, 320, 321, 322, 323, 324, 325, 326, and 327.

Other devices under the same FDA submission

4 devices cleared under K944211 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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