Clinical Diagnostic Solutions Recalls Hematology Control Material Due to Elevated MCV
Clinical Diagnostic Solutions is recalling Boule Con-Diff Tri-Level Hematology Control material because of elevated MCV results in specific lots.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 II, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Clinical Diagnostic Solutions is recalling 3,540 units of Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control. This product is used for in vitro diagnostic purposes to monitor the performance of multi-parameter hematology instruments.
The recall is being conducted because of elevated Mean Corpuscular Volume (MCV) results found in lots 1311-682, 1311-683, and 1311-684. The affected products have an expiration date of March 26, 2014. The specific part numbers involved are 501-605, 501-607, and 501-608.
The affected units were distributed nationwide in the United States as well as in Ivory Coast, Mexico, and the Philippines. Users of these hematology control materials should stop using the affected lots and contact Clinical Diagnostic Solutions for further instructions.
The recalled product
- 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.
- Manufacturer
- Clinical Diagnostic Solutions
- Hazard
- Affected units
- 3,540
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 (1)
- 1311-684 Exp. 3/26/2014 501-608 Lot# 1311-683 Exp. 3/26/2014
Distribution
Distributed nationwide across the United States.
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