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Boule Cal

CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Model 1 x 3.0mL · UDI-DI 00812137010223

510(k) clearances

Adverse events

Recalls

Facilities

Description

Boule Cal Hematology Calibrator is manufactured for calibration multi-parameter hematology analyzers.Multi-parameter hematology analyzers require regular calibration in order to produce accurate results on patient samples. Calibration can be accomplished by transferring information to the analyzer through fresh blood samples, which have been assayed by reference methods. A more direct and convenient approach is to use a calibrator material with System Specific Values (SSV) assigned. Boule Cal is such a material. Boule Cal is a stable suspension of red blood cells, white blood cells and platelets. Assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). A user analyzes Boule Cal on their instrument and computes calibration factors by comparing recovered values and assigned values. These factors provide the basis for making adjustments to the instrument.

Recalls

Date	Firm	Reason
2025-06-04	Siemens Healthcare Diagnostics, Inc.	Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
2011-10-25	Bio-Rad Laboratories, Inc.	It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.