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Terminated

Aeroset Direct HDL Reagent, LN 7D67-01

FDA Recall Z-0803-03 · Posted 2003-05-09

Recalling FirmAbbott Laboratories Diagnostic Div
Recall StatusTerminated
Date Initiated2003-03-28
Date Terminated2004-09-16
Product Quantity1409

Reason for Recall

Degredation prior to expiry date.

Firm Action

Firm sent letters on 3/28/2003 requesting laboratories destroy kits that remain for reimbursement.

Root Cause

Other

Distribution Pattern

Nationwide and to Mexico, Colombia, Canada, Brazil, Ecuador, Hong Kong, New Zealand, Germany, Dominican Republic, El Salvador, Venezuela, Bahamas, Argentina, Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981580HDLAbbott Laboratories · 1998-06-11

Official Source

View FDA Recall →

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

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