Abbott Gmbh & Co. KG: Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.

Recall number

Z-2401-2020

Recalling firm

Abbott Gmbh & Co. KG

Product

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

Status

Terminated

Initiated

2020-05-12

Posted

not on file

Terminated

2023-01-31

Reason

There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.

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

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.

Lot, serial or model codes

List Number: 03R67-01: All serial numbers

510(k) numbers

not on file

PMA numbers

not on file

Product code

JJE

Firm FEI

3002809144

Firm city

Wiesbaden

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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