Abbott Laboratories HPD/ADD 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Abbott Laboratories HPD/ADD
Lot Codes / Batch Numbers
list 7G96-01, lot number 94493M300
Products Sold
list 7G96-01, lot number 94493M300
Abbott Laboratories HPD/ADD is recalling Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 due to The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026