Product Description
Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)
Reason for Recall
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%.
Action Details
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.
Distribution Pattern
Worldwide distribution ---- USA including states of MN, CA, NJ, WA, IL, CO,and NY and countries of Canada, Spain, Bulgaria, UK, Lebanon, Russia, Columbia, South Africa, Italy, Sweden, Germany, Norway, Venezuela, Japan, Tunisia, Cyprus, The Netherlands, Greece, Israel, and India.
Code Information / Serial Numbers
The kit lots have the following lot numbers: 052534, 052592, 052296, 052536 (expiration date of 2007-02-09);and 052106 (exp. date 2006-08-09), and with storage requirements at between 2-8¿C. The nonconforming kit compoinent is the Negative Control (labeled ''CONTROL --''). There are two Negative Control lots affected. Both have the same expiration date of 2007-02-21 with one lot number being Ch.-B.502186301 (for kit lots 052534 and 052106) and the other lot number being Ch.-B.502186302 (for kit lots 052592, 052296 and 052536).
Public Record Disclaimer
This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.