Siemens Healthcare Diagnostics, Inc. IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ Systems Analyzers for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism. Recall
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ Systems Analyzers for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Catalog Number: LCLCM, Lot Number: 0019, Siemens Material Number: 10385383, IFU Reference: PILCLCM-11 {24}, 2014-02-19, PINLCLCM-11{24}, 2014-02-19, PIELCLCM-9{24}, 2014-02-19
Products Sold
Catalog Number: LCLCM, Lot Number: 0019, Siemens Material Number: 10385383, IFU Reference: PILCLCM-11 {24}, 2014-02-19; PINLCLCM-11{24}, 2014-02-19; PIELCLCM-9{24}, 2014-02-19
Siemens Healthcare Diagnostics, Inc. is recalling IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) Fo due to A typographical error regarding the expiration date was identified in the control module instructions for use.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A typographical error regarding the expiration date was identified in the control module instructions for use.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, KY, MA, MN, NY, PA, UT, VA
Page updated: Jan 10, 2026