Food, drugs, devices › Abbott Gmbh & Co. KG
Device recall: Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
Abbott Gmbh & Co. KG (Wiesbaden) initiated this device recall on 12 May 2020; FDA lists 1 product record under event 85686, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 31 Jan 2023. Initiation: voluntary: firm initiated. Abbott Gmbh & Co. KG has 16 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Abbott Gmbh & Co. KG, Wiesbaden, Germany.
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2401-2020 | Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics. | 421 serial numbers | Class II | Terminated | 24 Jun 2020 |
Context
Other enforcement events for Abbott Gmbh & Co. KG
All 16 events for Abbott Gmbh & Co. KG
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Jan 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.