Z-0364-04

ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing...

Name: Z-0364-04 ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing...
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2003-12-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-12-16 / Terminated

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing TRIS buffer with protein stabilizer, contained in... on 2003-12-16. The reason FDA records is "The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0364-04
Status: Terminated
Initiated: 2003-12-16
Posted: 2004-07-20
Terminated: 2004-07-20
Recalling firm: Abbott Medical
Product: ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing TRIS buffer with protein stabilizer, contained in ARCHITECT Folate Reagent Kit (Lists 6C12-20, 6C12-25, 6C12-30); Abbott Laboratories, Abbott Park, IL 60064 USA
Product code: CGN--
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.
FDA root cause: Other
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.
Quantity in commerce: 2,141 kits
Distribution: 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.
Product codes and lots: List 6C12Y: lots 06537M100Y, 09888M100Y, 06537M101Y, 05081M100Y, 07465M300Y and 10587M200Y. These diluent lots were packaged in the following reagent kit lots: List 6C12-20 (4 x 100 tests), lots06537M100 and 09888M100; List 6C12-25 (100 tests), lots 06537M101and 05081M100; List 6C12-30 (4 x 500 tests), lots 07465M300 and 10587M200.

Product code CGN--

K023397Class IIAbbott Architect FolateAbbott Laboratories / cleared 2002-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)