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Terminated

ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064

FDA Recall Z-0353-04 · Posted 2004-07-20

Recalling FirmAbbott Laboratories HPD/ADD/GPRD
Recall StatusTerminated
Product CodeCEC
Date Initiated2003-12-15
Date Terminated2004-07-22
Product Quantity1,364 kits

Reason for Recall

The calibrator lots may yield Free T4 values that are depressed.

Firm Action

Architect Free T4 Calibrator kits were recalled by letter dated 12/15/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the kits, and were requested to discontinue use and destroy the affected lots of product.

Root Cause

Other

Distribution Pattern

Nationwide and internationally to Abbott subsidiaries in Brazil, Canada, Germany, Japan, Singapore, Hong Kong, Thailand, Korea, Australia, Colombia, New Zealand, Venezuela and Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983417ABBOTT ARCHITECT FREE T4Abbott Laboratories · 1998-11-20

Official Source

View FDA Recall →

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

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