Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
Brand
Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Lot Codes / Batch Numbers
List Number: 03R67-01: All serial numbers
Products Sold
List Number: 03R67-01: All serial numbers
Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany is recalling Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics. due to There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamy. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, CO, FL, GA, KS, KY, LA, MD, MI, MN, MS, MO, NJ, NY, NC, OK, SC, SD, TN, TX, UT, VA, WI, PR
Page updated: Jan 10, 2026