Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Labo

FDA device recall Z-1130-03 · posted 2003-08-13 · Terminated

Recall details

Recalling firm

Abbott Laboratories HPD/ADD

Reason for recall

The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.

Action taken

The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, were recalled by letter dated 5/30/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the IMx kit, and were requested to discontinue use and destroy the affected lots of product. Abbott sent a Device Correction letter dated 6/4/03 to those accounts receiving the Architect Free T4 Calibrator kits, informing them of the problems experienced with the The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, made from the same raw material. The accounts were informed that the Architect Calibrator was performing as expected, but as a precaution recommended conducting a daily QC with non-Abbott Controls and to report back to Abbott any out of range non-Abbott control results.

Root cause

Other

Status

Terminated

Product code

CEC

Quantity affected

3247 kits

Distribution

Nationwide and internationally to Abbott subsidiaries in Ecuador, Uruguay, Argentina, Brazil, El Salvador, Canada, Germany, Japan, Singapore, Hong Kong, Thailand, Korea, Australia, Costa Rica, Grenada

Date initiated

2003-05-30

Date posted

2003-08-13

Date terminated

2003-09-16

Location

Abbott Park, IL

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