Z-0003-2007

Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)

Name: Z-0003-2007 Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)
Creator: Axis-Shield Diagnostics, Ltd.
Published: 2005-11-11
License: https://open.fda.gov/license/

Axis-Shield Diagnostics, Ltd. / initiated 2005-11-11 / Terminated

FDA source

Axis-Shield Diagnostics, Ltd. began a recall of Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200) on 2005-11-11. The reason FDA records is "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%". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0003-2007
Status: Terminated
Initiated: 2005-11-11
Posted: 2006-10-03
Terminated: 2007-03-03
Recalling firm: Axis-Shield Diagnostics, Ltd.
Product: Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)
Product code: NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
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%.
FDA 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 in commerce: 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.
Product codes and lots: 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).

Product code NHX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)