Class 2 Device Recall Alinity c Processing Module

• Date Initiated by Firm: May 12, 2020
• Create Date: June 18, 2020
• Recall Status: Terminated on January 31, 2023
• Recall Number: Z-2401-2020
• Recall Event ID: 85686
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
• Code Information: List Number: 03R67-01: All serial numbers
• Recalling Firm/ Manufacturer: Abbott Gmbh & Co. KG; Max-Planck-Ring 2; 65205; Wiesbaden Germany
• Manufacturer Reason for Recall: There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.
• FDA Determined Cause: Component design/selection
• Action: Abbott sent a notification dated May 12, 2020 titled, "Product Correction Urgent  Immediate Action Required," to customers. This Product Correction letter is to inform customers of an issue with the Alinity c system Optics Assembly (part number 3501627801). The firm has identified the potential for a nonlinear optics response due to an issue with the Alinity c optics. The issue is with the diffraction grating within the optics assembly and can result in a lower than expected absorbance value. The root cause of the issue is unknown and currently under investigation. The issue can be identified using an Optics diagnostic procedure. Instruments that pass this Optics diagnostic procedure do not exhibit and will not develop the nonlinear optics response. Abbott has tested multiple representative assays with different calibration types and wavelengths to understand the impact of the nonlinear optics response on the firm's clinical chemistry menu. The studies compared sample results obtained between an Alinity c with a confirmed normal optics to the results obtained from an Alinity c with confirmed defective optics. The studies show that four assays are impacted by the nonlinear optics response: Alkaline Phosphatase, Amylase, Creatine Kinase, and GammaGlutamyl Transferase. The impact on the test result is a false decrease in results. An Appendix is attached to the notification regarding the assay testing information. There is a potential to generate incorrect patient results for the following assays on the Alinity c system: Alkaline Phosphatase, Amylase, Creatine Kinase, and GammaGlutamyl Tansferase. Abbott recommends discontinuing testing on the impacted assays (Alkaline Phosphatase, Amylase, Creatine Kinase, and GammaGlutamyl Transferase) until an assessment of the optics can be completed. A firm representative will contact the customer to schedule the assessment to determine the potential impact to the optics assembly. If customers have forwarded t
• Quantity in Commerce: 421 serial numbers
• Distribution: U.S. States: AR, CA, CO, FL, GA, KS, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OK, SC, SD, TN, TX, UT, VA, WI, PR Worldwide distribution: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JORDAN, KENYA, MALAYSAI, MEXICO, NEW CALEDONIA, NORWAY, OMAN, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SERBIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, URUGUAY, and VIETNAM.
• 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.