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

Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container) The M-30D Diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray — recall Z-1320-2018

U.S. FDA — Device Enforcement · United States · 2018-01-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1320-2018
Date of alert: 2018-01-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Mindray DS USA, Inc. dba Mindray North America
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 2017060906

Reported risk: Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevated platelet background count.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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