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Terminated

Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20

FDA Recall Z-1377-04 · Posted 2004-08-17

Recalling FirmAbbott Laboratories Diagnostic Div
Recall StatusTerminated
Product CodeCGX
Date Initiated2004-07-27
Date Terminated2012-05-02
Product Quantity758

Reason for Recall

Precipitate formed in product.

Firm Action

Firm sent recall letters requesting destruction of kits in the field on July 27, 2004.

Root Cause

Other

Distribution Pattern

Nationwide and to Mexico, Columbia, Ecuador, Brazil, Puerto Rico, Domincan Republic, Canada, Germany, Singapore, Hong Kong, India, Thailand, Australia, New Zealand, Bahamas.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981799CREAAbbott Laboratories · 1998-07-22

Official Source

View FDA Recall →

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

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