Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
Clinical Diagnostic Solutions is recalling specific lots of Boule Con-Diff Hematology Control vials due to a received complaint.
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 classification is Class III, which by definition is unlikely to cause adverse health consequences, and no specific injuries or illnesses are reported in the source text.
Plain-English summary
Clinical Diagnostic Solutions, Inc. is recalling Boule Con-Diff Hematology Control vials, which are used for in vitro diagnostic purposes to monitor the performance of multi-parameter hematology instruments. The recall involves specific product parts and lot numbers, including Product Part 501-605 (Lot #1102-575 and Lot #1102-576), Product Part 501-607 (Lot #1102-576), and Product Part 502-012 (Lot #1102-574).
The recall was initiated following the receipt of a complaint. The source text does not specify the nature of the complaint or the exact defect. The affected products were distributed worldwide, including in the United States and in Brazil and Colombia.
Users of these hematology control vials should check their inventory for the specific lot numbers listed above. If the products are found, they should stop using them and contact Clinical Diagnostic Solutions for further instructions.
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
- 623
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 #1102-575 and Lot # 1102-576
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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FDA (Devices) · 2012-11-14
- ModerateClinical Diagnostic Solutions Recalls Hematology Control Material Due to Elevated MCV
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