FDA Medical Device Recalls (openFDA)
Clinical Diagnostic Solutions: Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Recall number
- Z-1436-2014
- Recalling firm
- Clinical Diagnostic Solutions
- Product
- Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Status
- Terminated
- Initiated
- 2013-02-24
- Posted
- 2014-04-09
- Terminated
- 2014-08-07
- Reason
- Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
- Root cause
- Under Investigation by firm
- Action
- Clinical Diagnostic Solutions sent a Notification letter dated February 26, 2014 to affected customers. The letter identified the affected product, problem and the actions to be taken. For questions contact Technical Support at 1-800-453-3328.
- Quantity
- 3,540
- Distribution
- Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.
- Lot, serial or model codes
- Product Part Number: 501-605 Lot# 1311-682 Exp. 3/26/2014 501-607 Lot# 1311-683, 1311-684 Exp. 3/26/2014 501-608 Lot# 1311-683 Exp. 3/26/2014
- 510(k) numbers
- ["K024173"]
- PMA numbers
- not on file
- Product code
- JPK
- Firm FEI
- 3002684533
- Firm city
- Plantation
- Firm state
- FL
- 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