Device recall: ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment…

Class II FDA enforcement event 85590. Recall start date: 24 Apr 2020. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when processed directly after the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted.

Class II, in the words of FDA

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

Abbott Gmbh & Co. KG started this device recall on 24 Apr 2020. The firm address in the FDA record is in Wiesbaden. FDA put the recall in Class II. FDA event 85590 has 1 product record. The first FDA enforcement report date is 3 Jun 2020. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MT, ND, NE, NJ, NV, NY, OH, OK, PA, RI, SC,…

Recalling firm

Abbott Gmbh & Co. KG, Wiesbaden, N/A, Germany.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 85590: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2117-2020	ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.	6087 Reagent Kits	Class II	Ongoing	3 Jun 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 16

Other events of the firm

Other FDA enforcement events of Abbott Gmbh & Co. KG
Initiated	Product (first record)	Type	Class	Records
19 Jun 2020	Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below	Device	Class II	1
12 May 2020	Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.	Device	Class II	1
9 Mar 2020	ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.	Device	Class II	1
24 Jan 2020	LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module	Device	Class II	1
7 Nov 2019	ARCHITECT HAVAB-G Calibrator, REF 6L27-01	Device	Class II	1
23 Oct 2019	Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada	Device	Class II	1
16 Sep 2019	Alinity ci Level Sensor, Bulk Solution	Device	Class II	3
10 Jun 2019	Alinity ci -series System Control Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Modul	Device	Class II	1
21 May 2019	The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-seri	Device	Class II	1
15 Apr 2019	Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system	Device	Class II	1

Abbott Gmbh & Co. KG: all 16 events

Official channels

FDA enforcement report Z-2117-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 85590. https://recallregister.com/fda/ii/85590/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CT, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MT, ND, NE, NJ, NV, NY, OH, OK, PA, RI, SC,…
What quantity of product is in FDA event 85590?: The FDA record gives this quantity: 6087 Reagent Kits
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.