Z-2401-2020Class II

Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics

Name: Z-2401-2020 Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics
Creator: Abbott Gmbh & Co. KG
Published: 2020-05-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-05-12 / Terminated / root cause: design

FDA source

Abbott Gmbh & Co. KG began a recall of Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics on 2020-05-12. FDA classified it as Class II and gives the reason as "There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2401-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-12
Posted: 2020-06-18
Terminated: 2023-01-31
Recalling firm: Abbott Medical
Product: Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: design
FDA root 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.
Product codes and lots: List Number: 03R67-01: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2401-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2401-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-18

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)