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Terminated

LDL Cholesterol Reagent (LDLD) Part No. 969706

FDA Recall Z-1099-04 · Posted 2004-07-20

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeMRR
Date Initiated2003-02-10
Date Terminated2004-12-02
Product Quantity291

Reason for Recall

Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.

Root Cause

Other

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K014103SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATORBeckman Coulter, Inc. · 2002-01-28

Official Source

View FDA Recall →

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

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