CAPILLARY CAPS

Additional Manufacturer Narrative

CUSTOMER INDICATED THAT THEY DO NOT HAVE ANY CAPILLARIES LEFT FROM A LOT THAT HAD NOT BEEN BREAKING FOR INVESTIGATION. THIS ISSUE IS UNDER INVESTIGATION. THE CAUSE FOR THE EVENT IS UNKNOWN.

Description of Event or Problem

CUSTOMER REPORTED THAT CAPILLARY CAPS WERE NOT FITTING WELL TO GLASS CAPILLARIES AND CAUSING GLASS CAPILLARIES TO BREAK. CUSTOMER ALSO REPORTED THAT OPERATOR HAD MINOR CUT ON THE FINGER DUE TO THIS INCIDENT. THERE WAS NO REPORT OF MEDICAL INTERVENTION DUE TO THIS INCIDENT.

Additional Manufacturer Narrative

(B)(4). ADDITIONAL INFORMATION:SIEMENS INVESTIGATION IDENTIFIED THAT A MATERIAL CHANGE MADE BY THE SUPPLIER HAS RESULTED IN CAPILLARY CAPS THAT ARE MORE DIFFICULT TO APPLY TO THE CAPILLARIES.AN URGENT FIELD SAFETY NOTICE #(B)(4) WAS SENT BY E-MAIL TO ALL AFFECTED SIEMENS HEALTHCARE DIAGNOSTICS REGIONAL OFFICES ON JANUARY 22, 2015 BOTH IN THE UNITED STATES AND ELSEWHERE FOR COMMUNICATION WITH AFFECTED CUSTOMERS. PLEASE NOTE: THESE CAPILLARY CAPS ARE AN "OFF THE SHELF" ITEM. SIEMENS PURCHASES THEM FROM A DISTRIBUTOR AND REPACKAGES THEM.