Z-1570-2008

Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C49-05...

Name: Z-1570-2008 Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C49-05...
Creator: Abbott Laboratories
Published: 2008-02-27
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-02-27 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C49-05 Intended for use in the verification of sensitivity... on 2008-02-27. The reason FDA records is "Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4 MasterCheck and Total T4 MasterCheck lots are not stable at the recommended storage condition of 2 to 8 degrees...". 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-1570-2008
Status: Terminated
Initiated: 2008-02-27
Posted: 2008-07-31
Terminated: 2008-11-05
Recalling firm: Abbott Medical
Product: Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C49-05 Intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott ARCHITECT i System. Abbott Laboratories, Abbott Park, IL 60064
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Reason for recall: Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4 MasterCheck and Total T4 MasterCheck lots are not stable at the recommended storage condition of 2 to 8 degrees Celsius through expiration dating. These lots may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Abbott sent a Product Recall letter dated 2/27/08, to all customers who received the affected product lots, informing them that the storage conditions are being changed to -10 degrees C or colder for all lots of material manufactured after lot numbers 82130M and 84110M until the cause has been determined and a corrective action has been implemented. All new shipments will contain additional instructions indicating that the ARCHITECT Free T4 and Total T4 MasterChecks are to be stored frozen until first use. Customers were requested to check their inventory for lot numbers 82130M and 84110M, discontinue use of the lots and destroy any remaining inventory. For lots 82140M, 82150M and 84120M, if they know the date the lot was received or the date it was thawed, they may continue to use lots if they have been stored at 2 to 8 degrees C unopened for less than 60 days. If the material has been stored at 2 to 8 degrees C for greater than 60 days or they do not know the number of days it has been thawed, they were instructed to discard the material. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the kits. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT in the U.S. Customers outside of the U.S., were requested to contact their local customer support representative.
Quantity in commerce: 128 units
Distribution: Worldwide Distribution --- USA including state of Puerto Rico and country of Canada.
Product codes and lots: lots 84110M, Exp 06/30/2008; 84120M, Exp 11/30/2008

Product code JJX

K984074Class IArchitect Total T4 Mastercheck, List No. 6C49-05Bio-Rad / cleared 1998-11-20

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)