Class 2 Device Recall STA Deficient VIII

• Date Initiated by Firm: March 04, 2020
• Create Date: April 10, 2020
• Recall Status: Terminated on November 10, 2021
• Recall Number: Z-1699-2020
• Recall Event ID: 85167
• 510(K)Number: K892859
• Product Classification: Test, qualitative and quantitative factor deficiency - Product Code GGP
• Product: STA - Deficient VIII, Product Code: 00725.; STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows:; (A) STA-R Max, Product Codes: 58989, 58990; (B) STA-R Evolution, Product Codes: 58986, 58987, 58988; (C) STA Compact Max, Product Codes: 59026, 59027; (D) STA Compact, Product Codes: 58978, 58979
• Code Information: All lots This cleaning sequence has been implemented in the following available software versions. Customers not possessing these software levels will be upgraded by Stago Field Support personnel: STA-R¿ Max (all serial numbers): Software version 4.05.04 or higher, and Methodology Update (MU) to enhance database version MS215. STA-R¿ Evolution (serial numbers higher than 8012756): Software version 3.04.09 or higher STA¿ Compact Max (all serial numbers): Software version 110.05 or higher.
• Recalling Firm/ Manufacturer: Diagnostica Stago, Inc.; 5 Century Dr; Parsippany NJ 07054-4607
• For Additional Information Contact: 973-631-1200
• Manufacturer Reason for Recall: A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased
• FDA Determined Cause: Nonconforming Material/Component
• Action: Stago notified on 3/4/20 end users of the risks to factor VIII tests in writing. Letters issued via email, US mail, and/or UPS overnight mail. Letter states reason for recall, health risk and action to take: To remove this cross-contamination risk, a special pre-wash has been developed for the concerned Stago methodology. It involves special washing of needle 1 before every factor VIII assay in order to eliminate any residual quantities of Emicizumab. This cleaning sequence has been implemented in the stated available software versions. Customers not possessing these software levels will be upgraded by Stago Field Support personnel. Completed enclosed acknowledgement coupon to Stago confirming you have read the letter and will apply the instructions Please fax to 1-973-644-9348 or e-mail toquality.systems@us.stago.com. For additional information, please contact your Stago Hotline at 1-800-725-0607. In addition- Since the Stago analyzer platforms are open systems, analyzer customers may be performing other factor VIII assays (e.g. LDTs, or other manufacturers factor VIII products) that Stago has no visibility to, or control over. Therefore an Information Letter issued to all other US customers of the analyzers, to alert customers to the risk that factor VIII testing on these Stago analyzers can be affected by the Emicizumab molecule, and to contact technical service teams for assistance.
• Quantity in Commerce: 3,225 units
• Distribution: Nationwide
• 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 = GGP and Original Applicant = AMERICAN BIOPRODUCTS CO.