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

FDA device recall Z-0782-03 · posted 2003-04-24 · Terminated

Recall details

Recalling firm

Abbott Laboratories HPD/ADD

Reason for recall

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

Action taken

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

Status

Terminated

Product code

JLS

Quantity affected

368 kits

Distribution

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

Date initiated

2003-03-31

Date posted

2003-04-24

Date terminated

2003-08-19

Location

Abbott Park, IL