Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0193-2013 — Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

U.S. FDA — Device Enforcement · United States · 2010-08-04 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0193-2013
Date of alert: 2010-08-04
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Clinical Diagnostic Solutions
Product category: device
Product type: Devices

Reported risk: Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0193-2013 — Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

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