FDA Medical Device Recalls (openFDA)
Clinical Diagnostic Solutions: Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Recall number
- Z-0191-2013
- Recalling firm
- Clinical Diagnostic Solutions
- Product
- Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Status
- Terminated
- Initiated
- 2011-03-24
- Posted
- 2012-11-02
- Terminated
- 2014-08-13
- Reason
- Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai
- Root cause
- Nonconforming Material/Component
- Action
- Clinical Diagnostic Solutions, Inc. sent a letter dated March 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm istructed the accounts to replace the assay sheet they were currently using with the new assay sheets enclosed. For an unused product they would need to discard. To correct the ranges in their instrument, they would need to scan in the new bar codes specific for their instrument type. For any questions customers were instructed to contact CDE Technical Support atl 800-453-3328. For questions regarding this recall call 954-791-1773.
- Quantity
- 197 vials
- Distribution
- Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. Foreign: Brazil and Colombia
- Lot, serial or model codes
- Product Part 502-012, Lot #1102-574
- 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