FDA Medical Device Recalls (openFDA)
Abbott Laboratories: 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
- Recall number
- Z-1570-2008
- Recalling firm
- Abbott Laboratories
- 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
- Status
- Terminated
- Initiated
- 2008-02-27
- Posted
- 2008-07-31
- Terminated
- 2008-11-05
- Reason
- 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
- 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
- 128 units
- Distribution
- Worldwide Distribution --- USA including state of Puerto Rico and country of Canada.
- Lot, serial or model codes
- lots 84110M, Exp 06/30/2008; 84120M, Exp 11/30/2008
- 510(k) numbers
- ["K984074"]
- PMA numbers
- not on file
- Product code
- JJX
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28