XN-L CHECK

Description of Event or Problem

A DEPUTY OF THE (B)(6) COUNTY SHERIFF'S OFFICE RECEIVED A REPORT THAT A CHILD CAME INTO POSSESSION OF AND INGESTED XN-L CHECK QUALITY CONTROL (QC) MATERIAL USED IN CLINICAL LABORATORIES FOR HEMATOLOGY ANALYZERS. THE DEPUTY DETERMINED THAT THE XN-L CHECK VIAL WAS OUTSIDE OF THE CLINICAL LABORATORY WHEN THE CHILD INGESTED CONTENTS OF THE VIAL. IT IS NOT KNOWN HOW MUCH OF THE MATERIAL WAS INGESTED OR IF THE CHILD RECEIVED MEDICAL TREATMENT. THE DEPUTY ADVISED THE INDIVIDUAL'S FAMILY TO CONTACT POISON CONTROL. SYSMEX PROVIDED THE XN-L CHECK PACKAGE INSERT, AND SAFETY DATA SHEET (SDS) EXEMPTION LETTER, RECOMMENDING THE FAMILY CONSULT WITH THEIR CHILD'S PHYSICIAN. THE INFORMATION WAS PROVIDED TO THE FAMILY BY THE DEPUTY.

Additional Manufacturer Narrative

THE SYSMEX HEMATOLOGY CONTROLS, CALIBRATORS AND REPORTABLE RANGE PRODUCTS SAFETY DATA SHEET (SDS) EXEMPTION LETTER STATES THE FOLLOWING: THE PRODUCTS DO NOT CONTAIN ANY HAZARDOUS CHEMICALS AT CONCENTRATIONS OF 1% OR GREATER. FURTHERMORE, THIS PRODUCT DOES NOT CONTAIN ANY KNOWN CARCINOGENS, CATEGORY ONE GERM CELL MUTAGENS, REPRODUCTIVE TOXICANTS, RESPIRATORY OR SKIN SENSITIZERS AT CONCENTRATIONS OF 0.1% OR GREATER. AS A RESULT, A SAFETY DATA SHEET IS NOT REQUIRED [REF.29CFR 1910.1200 (D) (5)]. THESE PRODUCTS ARE CLASSIFIED AS IN VITRO DIAGNOSTICS AND REGULATED BY THE FDA. ACCORDINGLY, ALL APPLICABLE PRECAUTIONS ARE STATED ON THE PRODUCT LABEL OR PACKAGE INSERT THAT ACCOMPANIES EACH PRODUCT. THE XN-L CHECK PACKAGE INSERT STATES THE FOLLOWING: XN-L CHECK IS USED FOR CONTROL AND CALIBRATION VERIFICATION OF SYSMEX XN-L ANALYZERS. XN-L CHECK IS FOR IN VITRO DIAGNOSTIC USE ONLY BY LABORATORY PROFESSIONALS OR APPROPRIATELY TRAINED PERSONNEL. DO NOT INJECT OR INGEST. (B)(6). BECAUSE NO KNOWN TEST METHOD CAN ASSURE COMPLETE ABSENCE OF HUMAN PATHOGENS, XN-L CHECK SHOULD BE HANDLED WITH APPROPRIATE PRECAUTIONS. PREFERRED COMPONENT CODE: BIOHAZARDOUS MATERIAL