Z-1539-05

XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott...

Name: Z-1539-05 XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott...
Creator: Abbott Laboratories MPG
Published: 2005-06-27
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-06-27 / Terminated

FDA source

Abbott Laboratories MPG began a recall of XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 60064 USA on 2005-06-27. The reason FDA records is "The XSYSTEMS Multiconstituent Controls accessory insert (commodity number 34-3067/R6) does not contain the correct control ranges for the AxSYM Opiates assay". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1539-05
Status: Terminated
Initiated: 2005-06-27
Posted: 2005-09-14
Terminated: 2006-01-18
Recalling firm: Abbott Medical
Product: XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 60064 USA
Product code: DIF Drug Mixture Control Materials
Reason for recall: The XSYSTEMS Multiconstituent Controls accessory insert (commodity number 34-3067/R6) does not contain the correct control ranges for the AxSYM Opiates assay.
FDA root cause: Other
Action: On 6/27/05, Abbott sent the customer letter via FedEx to all XSYSTEMS Multiconstituent Controls customers that received List Number 9687-12 lots 17270M100 and/or 18177M300 and/or AxSYM Opiates reagents (List Number 3B25-20) since June 01, 2004. The letters explained that the multiconstituent control ranges for morphine were not updated in the MCC Accesory insert at the same time they were updated in the AxSYM Opiates reagent package insert in 2004. The accounts were requested to review their current control ranges for the AxSYM Opiates assay, and verify that they are using either the control ranges in the AxSYM Opiates reagent package insert or control ranges established by their facility. They were also instructed to follow their facility''s normal policies and procedures for communicating with health care providers served by their laboratory. The accounts were requested to complete and return the enclosed reply sheet acknowledging the receipt of the letter and the dissemination of the letter to the laboratory manager/supervisor responsible for the assays.
Quantity in commerce: 4151 kits
Distribution: Nationwide, including Puerto Rico, and internationally to Argentina, Australia, Barbados, Bermuda, Brazil, Canada, Cayman Island, Chile, China/Hong Kong, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Germany, Honduras, Jamaica, Korea, Mexico, New Zealand, Panama, Peru, Singapore, St. Vincent, Thailand, Trinidad and Taiwan
Product codes and lots: lot numbers 17270M100 and 18177M300

Product code DIF

K873183Class ITdxr Multiconstit. Controls for Abused Drug AssaysAbbott Laboratories / cleared 1987-11-23

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)