FDA Medical Device Recalls (openFDA)
Diagnostic Chemicals, Ltd.: Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252
- Recall number
- Z-0536-2007
- Recalling firm
- Diagnostic Chemicals, Ltd.
- Product
- Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252
- Status
- Terminated
- Initiated
- 2006-09-06
- Posted
- 2007-02-27
- Terminated
- 2007-05-14
- Reason
- Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct
- Root cause
- Other
- Action
- Diagnostic Chemicals Ltd, Canada notified customers by telephone and fax on 9/06/06 and advised to use the cap label to determine concentration of the calibrators. Accounts were asked to confirm and acknowledge receipt of the letter.
- Quantity
- 38 kits
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot Number: 28423
- 510(k) numbers
- ["K042243"]
- PMA numbers
- not on file
- Product code
- JIX
- Firm FEI
- 3002806809
- Firm city
- Charlottetown Canada
- Firm state
- Prince Edward Island
- 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