FDA Medical Device Recalls (openFDA)
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 number
- Z-0212-2015
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-10-20
- Posted
- 2014-11-13
- Terminated
- 2017-03-31
- Reason
- A typographical error regarding the expiration date was identified in the control module instructions for use.
- Root cause
- Error in labeling
- Action
- Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction letter October 17, 2014, to US customers, and an Urgent Field Safety Notice issued October 16, 2014, outside the US. The letter identified the product the problem and the action needed to be taken by the customer. Customers are advised to review the notice with their medical directors. Customers should discard the control module IFU listed in table 1 and refer to table 2 for the list of revised IFU versions as noted on the notice. Finally, the customers should check the system for the expiration date and if correct, no further action is required. Field Correction Effectiveness Check should be returned via fax (312) 275-7795 within 30 days. For further questions please call 914-631-8000.
- Quantity
- 2212 units (92 units domestically & 2120 units internationally)
- Distribution
- Worldwide Distribution - US Distribution including the states of FL, KY, MN, MA, PA, UT, NY, VA and CA., and the countries of Algeria, Australia, Argentina, Austria, Belgium, Brazil, Bulgaria, Cameron, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Latvia, Macedonia, Mexico, Netherlands,Pakistan, Peru, Poland, Portugal, Rep. Korea, Romania, Russian Fed, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tadjikistan, Taiwan,Turkey, Unit. Arab Emir and Vietnam.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K023304"]
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28