FDA Medical Device Recalls (openFDA)
Axis-Shield Diagnostics, Ltd.: Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)
- Recall number
- Z-0003-2007
- Recalling firm
- Axis-Shield Diagnostics, Ltd.
- Product
- Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)
- Status
- Terminated
- Initiated
- 2005-11-11
- Posted
- 2006-10-03
- Terminated
- 2007-03-03
- Reason
- 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%.
- Root cause
- Other
- Action
- 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.
- Quantity
- 2,288 Kits
- Distribution
- 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.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- ["K021516","K023285"]
- PMA numbers
- not on file
- Product code
- NHX
- Firm FEI
- 3002808140
- Firm city
- Dundee
- Firm state
- Scotland
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28