FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD: IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
- Recall number
- Z-1131-03
- Recalling firm
- Abbott Laboratories HPD/ADD
- Product
- IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064
- Status
- Terminated
- Initiated
- 2003-05-30
- Posted
- 2003-08-13
- Terminated
- 2003-09-16
- Reason
- The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.
- Root cause
- Other
- 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.
- Quantity
- 1526 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, 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.
- Lot, serial or model codes
- list 2222-20, lot number 01550Q100
- 510(k) numbers
- ["K902834"]
- PMA numbers
- not on file
- Product code
- CEC
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28