Device recall: ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the…

Class III FDA enforcement event 82590. Recall start date: 9 Apr 2019. Status in the FDA record: Terminated. Termination date: 20 Dec 2019.

Reason for recall, in the words of FDA

Devices were delivered without the required dry ice.

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Abbott Laboratories started this device recall on 9 Apr 2019. The firm address in the FDA record is in Abbott Park, IL. FDA put the recall in Class III. FDA event 82590 has 9 product records. The first FDA enforcement report date is 22 May 2019. The record gives the status Terminated, with the termination date 20 Dec 2019.

FDA enforcement report The 9 product records

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.

Distribution to Latvia.

Recalling firm

Abbott Laboratories, Abbott Park, IL.

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

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

Products

9 product records in the event.

FDA event 82590: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1355-2019	ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.	1 unit	Class III	Terminated	22 May 2019
Z-1356-2019	ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.	1 unit	Class III	Terminated	22 May 2019
Z-1357-2019	ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.	1 unit	Class III	Terminated	22 May 2019
Z-1358-2019	ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.	2 units	Class III	Terminated	22 May 2019
Z-1359-2019	ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination…	2 units	Class III	Terminated	22 May 2019
Z-1360-2019	ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative…	3 units	Class III	Terminated	22 May 2019
Z-1361-2019	ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.	1 unit	Class III	Terminated	22 May 2019
Z-1362-2019	Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.	1 unit	Class III	Terminated	22 May 2019
Z-1363-2019	Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.	1 unit	Class III	Terminated	22 May 2019

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 III: The lowest of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class III: 6%
Product records in this event: 9Median of the firm: 1
Events of the firm on the register: 46

Other events of the firm

Other FDA enforcement events of Abbott Laboratories
Initiated	Product (first record)	Type	Class	Records
13 Nov 2025	Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20	Device	Class II	1
18 Sep 2025	Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 t	Device	Class II	1
18 Mar 2025	Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software vers	Device	Class II	5
14 Jun 2024	Alinity hq Analyzer, REF: 09P68-01	Device	Class II	1
21 Feb 2024	ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.	Device	Class II	1
31 Oct 2023	Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.	Food	Class II	1
19 Oct 2023	Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number	Device	Class II	1
19 Oct 2023	Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allow	Device	Class II	3
30 May 2023	Alinity ci-series System Control Module, REF: 03R70-01	Device	Class II	1
28 Mar 2023	Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton	Food	Class II	1

Abbott Laboratories: all 46 events

Official channels

FDA enforcement report Z-1355-2019The 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 82590. https://recallregister.com/fda/iii/82590/. 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: Distribution to Latvia.
What quantity of product is in FDA event 82590?: The event has 9 product records. The first record gives this quantity: 1 unit
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 6% of the 968 device events that started in 2019 are in Class III.