Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials because customers reported inaccurate MCV and RDW% values.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of or exposure to the product is not likely to cause adverse health consequences.
Plain-English summary
Clinical Diagnostic Solutions, Inc. is recalling Boule Con-Diff US Tri Pack hematology control vials. The affected products include Product part 501-605 and Product part 501-607, both with Lot #1005-549. These vials are used for in vitro diagnostic purposes to monitor the performance of multi-parameter hematology instruments.
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 Boule product were inaccurate. The source text does not specify the exact nature of the inaccuracy or the number of affected units beyond the lot and part numbers provided.
The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. The products were distributed nationwide. Users of these hematology controls should contact Clinical Diagnostic Solutions for further instructions on how to proceed with the recall.
The recalled product
- Product
- Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Manufacturer
- Clinical Diagnostic Solutions
- Affected units
- 690
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 501-607
- 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
- ModerateClinical Diagnostic Solutions Recalls Boule Con Diff US Tri Pack Hematology Controls
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
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