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Terminated

ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL bottle of ARCHITECT Folate Manual Diluent containing TRIS buffer with protein stabilizer; Abbott Laboratories, Abbott Park, IL 60064 USA

FDA Recall Z-0363-04 · Posted 2004-07-20

Recalling FirmAbbott Laboratories HPD/ADD/GPRD
Recall StatusTerminated
Product CodeCGN
Date Initiated2003-12-16
Date Terminated2004-07-20
Product Quantity226 kits

Reason for Recall

The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

Firm Action

Abbott notified their international affiliates via e-mail on 12/16/03 and 1/5/04. Device recall letters dated 12/16/03 and 12/31/03 will be sent to the end users by the affiliates, informing them of the unapproved serum albumin used to manufacture the folate products, and listing the impact to performance for each affected components. There are separate customer recall letters for each assay platform -- ARCHITECT, AxSYM and IMx.

Root Cause

Other

Distribution Pattern

There was no U.S. distribution. The products were shipped internationally through Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, Brazil, New Zealand, Columbia, Chile, Uruguay, United Kingdom, Venezuela, Dominican Republic, Argentina and Curacao.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023397ABBOTT ARCHITECT FOLATEAbbott Laboratories · 2002-12-16

Official Source

View FDA Recall →

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

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