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Terminated

TDx/TDxFLx Opiates Reagent, Product list number: 9673-60

FDA Recall Z-1229-04 · Posted 2004-07-28

Recalling FirmAbbott Health Products, Inc.
Recall StatusTerminated
Product CodeDJG
Date Initiated2004-05-28
Date Terminated2004-09-10
Product Quantity941 kits

Reason for Recall

Abbott Diagnostics Division has found that the oxymorphone cross-reactivity information in the 'Specific Performance Characteristics' section of the TDx/TDxFLx Opiates Reagent package insert (commodity number 32-2087/R5) does not match the current product performance.

Firm Action

A Device Correction Letter dated 5/28/04 was mailed to all customers. The letter explained the reason for the recall and provided specific instructions.

Root Cause

Other

Distribution Pattern

Distribution was to hospitals/laboratories

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K874485REVISED LABELING FOR OPIATESAbbott Laboratories · 1987-11-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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