FP, BCI TC GIEMSA STAIN

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT THE INTENSITY OF THE CELL COLORATION OF PERIPHERAL BLOOD SMEARS DIMINISHES RAPIDLY CAUSING THE INABILITY TO ACCURATELY IDENTIFY WHITE BLOOD COUNT (WBC) CELL POPULATIONS ON STAINED SMEARS WHEN USING LOT NUMBERS 0626169 AND 0626170 OF THE FP, BCI TC GIEMSA STAIN ON BOARD THE COULTER LH 750 SLIDE STAINER INSTRUMENT. BASED ON AVAILABLE INFORMATION, THE CUSTOMER HAS FILED A (B)(4) REPORT WITH THE (B)(4) COMPETENT AUTHORITIES. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT AND THERE IS A REMOTE PROBABILITY THAT THE HAZARD WILL CAUSE MEDICALLY REVERSIBLE OR TRANSIENT HEALTH CONSEQUENCES.

Additional Manufacturer Narrative

THE GIEMSA STAIN IS USED IN COMBINATION WITH OTHER ROMANOWSKY STAINS TO STAIN WHOLE BLOOD SMEARS PREPARED ON GLASS MICROSCOPE SLIDES IN THE LH SLIDESTAINER. THE ARE NO CLAIMS IN THE GIEMSA STAIN INSTRUCTIONS FOR USE (IFU) FOR STAIN STABILITY ON BOARD THE INSTRUMENT. PER LABELING, THE COULTER LH 750 SLIDE STAINER OPERATOR'S GUIDE STATES: BECKMAN COULTER PROVIDES NO PERFORMANCE CLAIMS FOR THIS INSTRUMENT. INFORMATION IS SUPPLIED TO THE CUSTOMERS AS REFERENCE MATERIAL ONLY AND (PERFORMANCE) IS NOT GUARANTEED BY BECKMAN COULTER. THE ISSUE IS CURRENTLY UNDER INVESTIGATION BY THE SUPPLIER. THE ROOT CAUSE IS UNKNOWN. GIEMSA STAIN, LOT NUMBER 0626169. INFORMATION FOR GIEMSA LOT NUMBER 0626170 IS PROVIDED BELOW: MANUFACTURED DATE: 03/16/2011; EXPIRATION DATE: 05/16/2011. LH750 SLIDE STAINER INFORMATION: BRAND NAME: COULTER LH 750 SLIDE STAINER. COMMON DEVICE NAME: SLIDE STAINER, AUTOMATED. PRODUCT CODE: KPA. PRODUCT CODE NAME: SLIDE STAINER, AUTOMATED. DEVICE CLASS; CLASS I; CLASSIFICATION PANEL: PATHOLOGY. C.F.R. SECTION: 864.3800- AUTOMATED SLIDE STAINER. (B)(4).