XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 6006

FDA device recall Z-1539-05 · posted 2005-09-14 · Terminated

Recall details

Recalling firm

Abbott Laboratories MPG

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

DIF

Quantity affected

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, Ecua

Date initiated

2005-06-27

Date posted

2005-09-14

Date terminated

2006-01-18

Location

Abbott Park, IL

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