IMMULITE Calcitonin Control Module — Class III medical device recall Z-0212-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-11-19, distributed in CA, FL, KY, MA, MN, NY, PA, UT…. A typographical error regarding the expiration date was identified in the control module instructions for use.
| Recall number | Z-0212-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2014-10-20 |
| Classified | 2014-11-13 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2017-03-31 |
| Distributed | CA, FL, KY, MA, MN, NY, PA, UT, VA |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EE, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IQ, IT, JO, KR, LV, MX, NL, PE, PK, PL, PT, RO, RS, SA, SE, SG, SI, SK, TR, TW, VN, ZA |
| Lot numbers | 0019 |
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.
Reason for recall
A typographical error regarding the expiration date was identified in the control module instructions for use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0212-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.