BD COLORPAC GIARDIA/CRYPTOSPORIDIUM TEST KIT

Additional Manufacturer Narrative

THE BD COLORPAC CRYPTOSPORIDIUM/GIARDIA TEST KIT IS AN OEM (ORIGINAL EQUIPMENT MANUFACTURER) FROM (B)(4). BD WAS NOTIFIED IN FEBRUARY / MARCH 2004, THAT (B)(4) HAD IDENTIFIED TWO KIT LOTS THAT SHOULD BE RECALLED: 071093 AND 071138 RESPECTIVELY, DUE TO AN INCREASE IN FALSE POSITIVE CRYPTOSPORIDIUM RESULTS. ONLY THE KIT LOT 071093 WAS DISTRIBUTED BY BD. THIS KIT LOT WAS RECALLED BY BD IN MARCH 2004. THE (B)(4) DISTRICT OFFICE WAS ALSO INFORMED OF THE PRODUCT RECALL. AT THE TIME OF THE RECALL, A VENDOR CORRECTIVE / PREVENTIVE ACTION REPORT ((B)(4)) WAS SENT TO (B)(4) TO ADDRESS THE FALSE POSITIVE CRYPTOSPORIDIUM ISSUE. BD AND (B)(4) AGREED TO A CORRECTIVE ACTION PLAN; FOLLOWING IS A SUMMARY: CONTINUE TESTING KITS ACCORDING TO CURRENT QC RELEASE PROCEDURE, IMPLEMENT SUPPLEMENTAL KIT TESTING OF A PANEL OF AT LEAST 20 OVA & PARASITE NEGATIVE STOLL SPECIMENS, WEEKLY TELECONFERENCES WITH BD TO REVIEW FALSE POSITIVE INVESTIGATION RESULTS AND ACTION ITEM, BD PERFORMED VENDOR AUDIT AT FACILITY, REVISE PRODUCT INSERT TO PROVIDE MORE DIRECT INSTRUCTIONS ON CORRECT TEST INTERPRETATION. A COPY OF THE HEALTH PROFESSIONALS' MEDWATCH FORM HAS BEEN FORWARDED TO THE VENDOR. THE VENDOR HAS SUBMITTED A STATUS REPORT FOR THEIR RECALL, Z-770-4, TO THE (B)(4) DISTRICT OFFICE OF THE US FOOD AND DRUG ADMINISTRATION. THIS REPORT HAS REQUESTED CLOSURE OF THE RECALL BASED ON THE VENDOR CORRECTIVE ACTIONS.

Description of Event or Problem

RECEIVED MEDWATCH FROM HEALTH PROFESSIONAL. MEDWATCH REFERENCED PERFORMANCE ISSUES WITH THE BD COLORPAC GIARDIA/CRYPTOSPORIDIUM TEST KIT AND THE CUSTOMER'S STUDY FINDINGS.