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Terminated

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.

FDA Recall Z-1436-2014 · Posted 2014-04-09

Recalling FirmClinical Diagnostic Solutions
Recall StatusTerminated
Product CodeJPK
Date Initiated2013-02-24
Date Terminated2014-08-07
Product Quantity3,540

Reason for Recall

Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.

Firm Action

Clinical Diagnostic Solutions sent a Notification letter dated February 26, 2014 to affected customers. The letter identified the affected product, problem and the actions to be taken. For questions contact Technical Support at 1-800-453-3328.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024173CDS 3-PD HEMATOLOGY CONTROLSClinical Diagnostic Solutions, Inc. · 2003-01-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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