Device Recall DIASTAT AntiCCP test kit 의 리콜

Recall

36018

Class 3

Z-0003-2007

2005-11-11

2006-10-03

Terminated

United States

2007-03-03

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47623

The preservative sodium azide used in the kit negative control (part number fcom175) was at the wrong concentration - the kit negative control contains 0.2% sodium azide rather than the intended 0.1%.

Advisory letter was sent to customers informing them of the increased sodium azide content. A specific letter was sent to each customer / distributor informing them of the misformulation. The content of the letter referred to the specific kits received by each customer. The letter informed users about the additional risk relating to double azide concentration. The outcome of the risk evaluation was as follows: 1) There is no impact to product performance and hence patient results because of this. 2) The increase in the sodium azide concentration changes the hazard status from ''No significant hazard'' to ''Harmful'', with the following additional risk phrases R22 (harmful if swallowed) and R32 (contact with acids liberates toxic gas). The accompanying safety phrases are S23 (do not breathe fumes), S26 (in case of contact with eyes, rinse immediately with plenty of water and seek medical advice), S46 (if swallowed, seek medical advice immediately and show this container or label) and S61 (avoid release to environment, refer to special instructions/safety data sheets). 3) The risk of the increase in sodium azide concentration in the Kit Negative Conrol to the end user is deemed to be minimal due to the low volume of the Negative Control. The letter states that the product can still be safely used and users should be aware of and take notice of the advisory letter.