FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD: Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
- Recall number
- Z-0782-03
- Recalling firm
- Abbott Laboratories HPD/ADD
- Product
- Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
- Status
- Terminated
- Initiated
- 2003-03-31
- Posted
- 2003-04-24
- Terminated
- 2003-08-19
- Reason
- Lot gives lower specimen results compared to results generated with other lots.
- Root cause
- Other
- Action
- Recalled by telephone calls and follow-up letters dated 3/31/03. The accounts were informed of the depressed patient specimen results, and were requested to discontinue use and destroy any of the three affected lots found in inventory. The accounts were advised to notify physicians of the lower patient results observed with these lots and suggest review of the patient results to determine any impact on patient management.
- Quantity
- 368 kits
- Distribution
- Nationwide, Canada, Columbia, England, Japan, Australia, New Zealand and Singapore
- Lot, serial or model codes
- list 6C26-27, lot 95651M201 list 6C26-22, lots 95651M200, 95651M202
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JLS
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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