· CELL-DYN 3700, List Numbers: 02H31-01, (SL). Registration number: 10055310993 for Model SL. CELL-DYN 3500, List Numbers: 91340-01, (CS), 91350-01, (SL), Registration Number: 10055310618 for Model SL, Registration Number: 10055310575 for Model CS. CELL-DYN 3200, List Numbers: 04H59-01, (CS), 04H60-01, (SL), Registration Number: 10055310800 for Model SL, Registration Number: 10055310797 for Model CS. CELL-DYN 3000, List Numbers: 9123-01, (CS), 91325-01, (SL), Registration Number: 10055310124 for Model SL, Registration Number: 10055310123 for Model CS 의 안전성 경고

Safety alert

787

2004-07-01

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

Discrepancy in the results of the total white blood cell (vbc) count in the sample of a thalassemia patient, when using the cell-dyn 3700 equipment. the result of cell-dyn 3700 for woc (optical white cell count) was significantly higher than the wbc count determined by the manual method. the source of interference for the woc could not be determined through the information received from the client, but it should be noted that the nrbcs (nucleated red blood cells) present in the sample were being included in the woc, making the count imprecise. the woc parameter is available on the cell-dyn 3700, cell-dyn 3500 and cell-dyn 3200 devices.

The WOC parameter is available on the CELL-DYN 3700, CELL-DYN 3500, CELL-DYN 3200 and CELL-DYM 3000 equipments. Note that the WOC on the CELL-DYN 3000 is called the WBC (total white cell). The WOC in these equipments was designed to apply thresholds, which exclude NRBCs from the WBC analysis. This ability is reflected in product labeling, which currently states that the WOC will provide an accurate estimate of WBCs in patient samples containing NRBCs. While this is true for the vast majority of samples, an investigation by Abbott demonstrated that the WOC result in CELL-DYN 3700 was significantly greater than WBC as determined by haemocytometry in a patient with a high number of NRBC s (> 100 NRBC / 100 WBC s). We are therefore taking the opportunity to inform users that this phenomenon may occur, and also to review the Operations Manuals to reflect this information. ACTIONS REQUIRED WIC ALERTS. WOC or KWOC - If a reported WBC value displayed on the screen your analyzer has one of the WIC, WOC or KWOC descriptor alerts next to it, refer to the list of potentially interfering substances in the Operation Manual for your CELL-DYN 3000 Series Equipment, and follow your lab procedures to confirm the result. ALERTS for NRBC - If a reported WBC value displayed on your analyzer screen has NRBC signaling next to it, review the smear to check for NRBCs and follow your laboratory's review criteria. If NRBCs are present, these should be quantified according to your laboratory procedures. If WBC correction is required, proceed as follows: · On the CELL-DYN 3500 and CELL-DYN 3700 Instruments, correct the WIC value and use the resulting number to confirm the WOC result. If there are no other suspicious signs, the corrected WIC (or WOG value confirmed) can be reported. · On the CELL-DYN 3200 instrument, analyze the patient sample in the NOC mode, correct the NOC value and use the resulting number to confirm the WOC result. If there are no other suspicious signs, the corrected NOC (or confirmed WOC value) can be reported. · On the CELL-DYN 3000 Instrument, check a smear for the presence of NRBCs and check the WBC count by an alternate method. If you have sent your CELL-DYN 3700, CELL-DYN 3500, CELL-DYN 3200 or CELL-DYM 3000 to another laboratory, please provide a copy of this letter to you.