Class 2 Device Recall ARCHITECT Prolactin MasterCheck

• Date Initiated by Firm: July 06, 2007
• Date Posted: September 18, 2007
• Recall Status: Terminated on May 18, 2008
• Recall Number: Z-1222-2007
• Recall Event ID: 38439
• 510(K)Number: K984324
• Product Classification: in vitro diagnostic control - Product Code JJX
• Product: ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with protein (bovine) stabilizers, and 4 - 2 mL bottles of Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 containing prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers; Abbott Laboratories, Abbott Park, IL 60064, list 6C27-05
• Code Information: list 6C27-05, lot 82900M
• FEI Number: 1415939
• 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 Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8 degrees C through the expiration dating (15 months). The MasterChecks may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect iSystem Operations Manual.
• FDA Determined Cause: Other
• Action: Abbott sent a Product Correction letter dated 7/6/07, to all customers who received the affected product lot, informing them that the ARCHITECT Prolactin MasterChecks may not be stable at the recommended storage condition of 2 to 8 degrees Celsius (C) through expiration dating (15 months). Labeling is being permanently updated to indicate that ARCHITECT Prolactin MasterChecks are to be stored frozen until first use. After thawing, ARCHITECT Prolactin MasterChecks can be stored unopened at 2-8 degrees C for thirty days or until expiration which ever occurs first. All future shipments will contain updated storage and handling conditions of the ARCHITECT Prolactin MasterCheck. They were requested to check their inventory to see if they have any remaining inventory of lot number 82900M. If they know the date the lot was received or the date it was thawed, they may continue to use the ARCHITECT Prolactin MasterChecks if it has been stored at 2 to 8 degrees C unopened for less than 30 days. If the material has been stored at 2 to 8 degrees C for greater than 30 days or they do not know the number of days it has been thawed, they were instructed to discard the material. Reimbursement for discarded kits will be provided based on information provided in the Customer Reply form. Until labeling is updated, it will be necessary to use an alternate material for verification of sensitivity, calibration linearity, and the reportable range of the ARCHITECT Prolactin assay. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the kits, and to retain a copy of the letter for their records. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT in the U.S. The accounts were requested to complete and fax back the customer reply form, acknowledging the receipt and understanding of the correction letter. Customers outside of the U.S., were requested to contact their local customer support representative.
• Quantity in Commerce: 57 kits
• Distribution: Nationwide and Canada.
• 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