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Terminated

Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

FDA Recall Z-0782-03 · Posted 2003-04-24

Recalling FirmAbbott Laboratories HPD/ADD
Recall StatusTerminated
Product CodeJLS
Date Initiated2003-03-31
Date Terminated2003-08-19
Product Quantity368 kits

Reason for Recall

Lot gives lower specimen results compared to results generated with other lots.

Firm Action

Recalled by telephone calls and follow-up letters dated 3/31/03. The accounts were informed of the depressed patient specimen results, and were requested to discontinue use and destroy any of the three affected lots found in inventory. The accounts were advised to notify physicians of the lower patient results observed with these lots and suggest review of the patient results to determine any impact on patient management.

Root Cause

Other

Distribution Pattern

Nationwide, Canada, Columbia, England, Japan, Australia, New Zealand and Singapore

Official Source

View FDA Recall →

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

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