IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
FDA Recall Z-1131-03 · Posted 2003-08-13
Recalling FirmAbbott Laboratories HPD/ADD
Recall StatusTerminated
Product CodeCEC
Date Initiated2003-05-30
Date Terminated2003-09-16
Product Quantity1526 kits
Reason for Recall
The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.
Firm Action
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
Distribution Pattern
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, St. Lucia, Bermuda, Antigua, Panama, Guatemala, Mexico, Colombia, Jamaica, Paraguay, Peru, Chile, Dominican Republic, United Kingdom, New Zealand, Trinidad & Tabago, St. Vincent, Barbados, Curacao, St. Kitts, Anguilla, Turks & Caicos Islands, Cayman Islands, Germany and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.