Clinical Diagnostic Solutions Recalls Boule Con Diff US Tri Pack Hematology Controls
Clinical Diagnostic Solutions is recalling Boule Con Diff US Tri Pack hematology controls due to customer reports of inaccurate MCV and RDW% values.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2. The hazard involves inaccurate diagnostic control values, which is a functional defect rather than a direct physical injury risk, fitting the Moderate category for low-risk issues.
Plain-English summary
Clinical Diagnostic Solutions, Inc. is recalling the Boule Con Diff US Tri Pack, a product used for in vitro diagnostic purposes to monitor the performance of multi-parameter hematology instruments. The recall involves Product part 501-605, Lot #1005-549, and Product part 501-607, Lot #1005-549.
The recall was initiated after the company received reports from customers stating that the Mean Corpuscular Volume (MCV) values and Red Cell Distribution Width percentage (RDW%) recovered for the product were inaccurate. The source text does not specify the exact nature of the discrepancy or the number of affected units.
This product is distributed nationwide. Users of these hematology controls should stop using the affected lots and contact Clinical Diagnostic Solutions for further instructions or a return.
The recalled product
- Product
- Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Manufacturer
- Clinical Diagnostic Solutions
- Affected units
- 532
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product part 501-605
- Lot #1005-549
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Clinical Diagnostic Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Clinical Diagnostic Solutions
See all →- ModerateClinical Diagnostic Solutions Recalls Hematology Control Material Due to Elevated MCV
FDA (Devices) · 2014-04-16
- LowClinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
FDA (Devices) · 2012-11-14
- LowClinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
FDA (Devices) · 2012-11-14
- LowClinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
FDA (Devices) · 2012-11-14
- LowClinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
FDA (Devices) · 2012-11-14
Same hazard · inaccurate diagnostic values
See all →- HighSysmex XN-Series Hematology Analyzers Recalled for Potential Elevated Values
FDA (Devices) · 2016-06-22