IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic u

FDA device recall Z-0212-2015 · posted 2014-11-13 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

A typographical error regarding the expiration date was identified in the control module instructions for use.

Action taken

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.

Root cause

Error in labeling

Status

Terminated

Product code

JJY

Quantity affected

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

Date initiated

2014-10-20

Date posted

2014-11-13

Date terminated

2017-03-31

Location

Tarrytown, NY

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