Recall Z-0212-2015 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
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 hyperparathyroidi
| Date | Nov 13, 2014 (initiated Oct 20, 2014) |
| Status | Terminated |
| 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, |
| 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, Ger |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023304 | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL Diagnostic Products Corp., Dec 9, 2002 |