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U.S. Department of Health and Human Services

Class 3 Device Recall Architect LH MasterCheck.

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  Class 3 Device Recall Architect LH MasterCheck. see related information
Date Initiated by Firm September 05, 2008
Date Posted November 13, 2008
Recall Status1 Terminated 3 on March 18, 2010
Recall Number Z-0216-2009
Recall Event ID 49427
510(K)Number K984323  
Product Classification Single (specified) analyte controls (assayed and unassayed). - Product Code JJX
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.


Code Information Lot Number: 82520M.
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Abbott Customer Support
877-422-2688
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJX and Original Applicant = BIO-RAD
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