Lower risk Medical device recall · FDA · Published April 9, 2019

Abbott ARCHITECT Intact PTH Calibrators Recall: Missing Dry Ice

Abbott recalls ARCHITECT Intact PTH Calibrators due to delivery without required dry ice. This affects lab equipment used for measuring intact PTH in blood tests.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1358-2019Medical device Abbott ›

Lower-risk recall

Devices were delivered without the required dry ice.

Take action

Contact the company

Recalling firmAbbott Laboratories100 Abbott Park Rd Bldg Ap8b · Abbott Park, IL 60064-3502

✎ GovInfoNow plain-language explainer

Abbott is recalling ARCHITECT Intact PTH Calibrators because they were shipped without the necessary dry ice. This could lead to improper calibration of blood tests for intact PTH levels in humans. Read more at govinfonow.com/recall/68371-abbott-architect-intact-pth-calibrators-recall-missing-dry-ice.

Source Summary by GovInfoNow · govinfonow.com/recall/68371-abbott-architect-intact-pth-calibrators-recall-missing-dry-ice · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1358-2019

Cite this page

“Abbott ARCHITECT Intact PTH Calibrators Recall: Missing Dry Ice.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68371-abbott-architect-intact-pth-calibrators-recall-missing-dry-ice. Based on FDA recall #Z-1358-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1358-2019%22&limit=1).

Abbott Laboratories voluntarily recalled ARCHITECT Intact PTH Calibrators distributed to Latvia after devices were delivered without required dry ice, according to the Food and Drug Administration on April 9, 2019.

How to tell if you have it

Brand: Abbott
Product: ARCHITECT Intact PTH Calibrators
Lot: 01018H000
LN: 8K25-04

The hazard

The ARCHITECT Intact PTH Calibrators, used for the calibration of the ARCHITECT iSystem for quantitative determination of Intact PTH in human serum and plasma, were delivered without the required dry ice.

Context

GovInfoNow's records show Abbott Laboratories has 33 other recalls on record since May 14, 2012. Other recent recalls include a November 13, 2025 correction for potential performance issues in the Alinity ci-series System Control Module and a September 18, 2025 software issue for the Abbott Alinity hq Analyzer that may result in incorrect results.

How to tell if you have this one

Check for the model number LN 8K25-04 and lot number 01018H0: these calibrators were shipped without dry ice.

Brand
Abbott
Category
Medical device

FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Terminated
Distribution
Distribution to Latvia.

Recall number	Product, codes & lots	Quantity
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.; LN 1L76-01; Lot 46K15718	1 unit
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.; LN 4P72-01; Lot 902920500	1 unit
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.; LN 8K25-12; Lot 01018I000	1 unit
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.; LN 8K25-04; Lot 01018H000	2 units
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 of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.; LN 3P25-11; Lot 94347UIOO	2 units
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 determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.; LN 3P25-02; Lot 93284UIOO	3 units
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.; LN 09P3501; Lot 84347UN18	1 unit
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.; LN 5P78-10; Lot 18004181	1 unit
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.; LN 5P78-11; Lot 18005182	1 unit

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for model number LN 8K25-04 and lot number 01018H000 on the calibrator.

How this recall unfolded

Recall timeline

FDA terminated this recall 8 months after the firm started it.

Apr 9, 2019Firm started the recall
May 16, 2019FDA classified it Class III
May 22, 2019Published in FDA’s Enforcement Report
Dec 20, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this product?

Check the model and lot number to see if it matches the recalled items. No specific action is required beyond checking.

Is there a risk of injury from this product?

The recall is for shipping issues, not direct injury risk. The danger level is low.

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Link to this recall

<a href="https://govinfonow.com/recall/68371-abbott-architect-intact-pth-calibrators-recall-missing-dry-ice">Abbott ARCHITECT Intact PTH Calibrators Recall: Missing Dry Ice (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1358-2019 (April 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1358-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.