Z-0792-2007

ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test kits), 07K60-25 (100...

Name: Z-0792-2007 ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test kits), 07K60-25 (100...
Creator: Abbott Laboratories, Inc
Published: 2007-03-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-03-28 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test kits), 07K60-25 (100 test kits)and 07K60-30 (4 x 500 test kits)... on 2007-03-28. The reason FDA records is "If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0792-2007
Status: Terminated
Initiated: 2007-03-28
Posted: 2007-05-09
Terminated: 2007-09-25
Recalling firm: Abbott Medical
Product: ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test kits), 07K60-25 (100 test kits)and 07K60-30 (4 x 500 test kits); manufactured by Abbott Ireland Diagnostic Division, Lisnamuck, Longford, Ireland.
Product code: CGN Acid, Folic, Radioimmunoassay
Reason for recall: If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Notification Letters were sent to all customers who received the ARCHITECT Folate Reagent on 03/28/07. Customers were provided with instructions on how to conduct a Wash Buffer Unload procedure and were requested to perform this action daily. Customers were also asked to contact their local Abbott Customer Support Rep to schedule an Internal Decontamination procedure on the ARCHITECT System. Firm recalling to the user (laboratory) level.
Quantity in commerce: 3866 units.
Distribution: Folate Reagent distributed to the following countries: Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Finland, France, Greece, Hungary, Ireland, Israel, Italy, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Trinidad and Tobago, Turkey, UAE, United Kingdom. No US distribution.
Product codes and lots: Product Control/Lot # (For List #07K60-20): 42908JN00, 42964JN00 and 42905JN00; (For List #07K60-25): 42909JN00, 42965JN00 and 42906JN00; (For List #07K60-30): 42910JN00, 42966JN00, 42907JN00, and 42931JN00.

Product code CGN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)