Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
- Recall Initiated
- May 12, 2020
- Terminated
- January 31, 2023
- Recall Number
- Z-2401-2020
- Quantity
- 421 serial numbers
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.
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.
Lot / Code Info
List Number: 03R67-01: All serial numbers
Root Cause
Component design/selection
Action Taken
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