Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials due to a received complaint. The product is used to monitor multi-parameter hematology instruments.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which the rubric defines as typically unlikely to cause adverse health consequences, corresponding to a Low severity score.
Plain-English summary
Clinical Diagnostic Solutions, Inc. in Plantation, FL is recalling Boule Con-Diff hematology control vials. The specific products involved include 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). These items are intended 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 complaint. The source text does not specify the nature of the complaint or the specific defect. The agency has classified this recall as Class III.
The affected products were distributed worldwide, including in the United States (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, and WY) and in Brazil and Colombia. The source text does not provide instructions for consumers or healthcare providers on how to handle the recalled items.
The recalled product
- Product
- Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Manufacturer
- Clinical Diagnostic Solutions
- Hazard
- Affected units
- 197
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 502-012
- Lot #1102-574
Distribution
Part of a larger recall action
This product is one of 3 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 3 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
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- LowClinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
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- LowClinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
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Similar recalls
- LowClinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
FDA (Devices) · 2012-11-14
- ModerateClinical Diagnostic Solutions Recalls Hematology Control Material Due to Elevated MCV
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