IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.
Reported: March 15, 2017 Initiated: January 4, 2017 #Z-1420-2017
Product Description
IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.
Reason for Recall
DHEA-S causes falsely elevated progesterone results.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 9076
- Distribution
- US Nationwide distribution including Puerto Rico
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 9076.
Why was this product recalled? ▼
DHEA-S causes falsely elevated progesterone results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2017. Severity: Moderate. Recall number: Z-1420-2017.
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