FDA Medical Device Recalls (openFDA)
Abbott Laboratories: Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064. ARCHITECT LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott ARCHITECT i System.
- Recall number
- Z-0216-2009
- Recalling firm
- Abbott Laboratories
- Product
- Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064. ARCHITECT LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott ARCHITECT i System.
- Status
- Terminated
- Initiated
- 2008-09-05
- Posted
- 2008-11-13
- Terminated
- 2010-03-18
- Reason
- The values listed in the Architect LH MasterCheck, Lot 82520 data sheet are incorrect. When MasterChecks do not perform as intended, the integrity of the system cannot be verified and patient results would not be generated. Other commercially available materials are available to customers in order to meet CLIA requirements.
- Root cause
- Error in labeling
- Action
- A Product Correction, Immediate Action Required letter and Customer Reply Form dated 9/5/08 were sent to all Architect LH MasterChecks (List Number 6C25-05) customers who received Lot 82520M. Customers were informed that the values listed in the Architect LH MasterCheck Lot 82520 data sheet are incorrect. Customers were requested to check their inventory for the affected lot, and if any kits were found, to substitute the values printed on the data sheet with the values supplied in the letter. In addition, Customers were requested to keep a copy of the letter on file and to complete the Customer Reply Form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for the Architect LH MasterCheck testing, and fax it to Abbott by 9/19/08 at 1-800-777-0051. Follow-up telephone calls will be placed to customers who do not provide a written reply via the Customer Reply Form. U.S. Customers please contact Abbott Laboratories Customer Service at 1-877-422-2688 for questions regarding this information.
- Quantity
- 30 kits
- Distribution
- Nationwide Distribution including Arizona, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Missouri, Montana, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah and Virginia.
- Lot, serial or model codes
- Lot Number: 82520M.
- 510(k) numbers
- ["K984323"]
- 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