ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.
FDA device recall Z-0353-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Reason for recall
- The calibrator lots may yield Free T4 values that are depressed.
- Action taken
- 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
- Status
- Terminated
- Product code
- CEC
- Quantity affected
- 1,364 kits
- Distribution
- Nationwide and internationally to Abbott subsidiaries in Brazil, Canada, Germany, Japan, Singapore, Hong Kong, Thailand, Korea, Australia, Colombia, New Zealand, Venezuela and Taiwan.
- Date initiated
- 2003-12-15
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-22
- Location
- Abbott Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT ARCHITECT FREE T4 (K983417) | Abbott Laboratories | 1998-11-20 |