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Terminated

Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050.

FDA Recall Z-0973-03 · Posted 2003-07-02

Recalling FirmPerkinElmer LIfe Sciences Inc
Recall StatusTerminated
Date Initiated2002-05-16
Date Terminated2008-10-24
Product Quantity10 kits

Reason for Recall

The CSF Gels were manufactured incorrectly resulting in irregular wavy bands.

Firm Action

The firm contacted the consignee by telephone on 5/16/2002.

Root Cause

Other

Distribution Pattern

The kits were shipped to one (1) consignee located in California.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K843122RESOLVE-CSFIsolab, Inc. · 1984-11-30

Official Source

View FDA Recall →

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

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