Boule Con-Diff Hematology Control For in vitro diagnostic use as a… — Class III medical device recall Z-0191-2013

Terminated recall by Clinical Diagnostic Solutions, reported 2012-11-14, distributed in AL, AR, AZ, CA, CO, DE, FL, GA…. Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-60

Recall number	`Z-0191-2013`
Product type	Medical device
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Clinical Diagnostic Solutions, Plantation, FL, United States
Recall initiated	2011-03-24
Classified	2012-11-02
Reported by FDA	2012-11-14
Terminated	2014-08-13
Distributed	AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV, WY
Countries outside the US	BR, CO
Quantity	197 vials
Lot numbers	`1102-574`
Model numbers	`502-012`

Product

Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0191-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.