Abbott Laboratories: Devices were delivered without the required dry ice.

Agency Publication Date: May 16, 2019

Affected Products

Product: 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

Lot Numbers:

46K15718

Product: 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

Lot Numbers:

902920500

Product: 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

Lot Numbers:

01018I000

Product: 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

Lot Numbers:

01018H000

Product: 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

Lot Numbers:

94347UIOO

Product: 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

Lot Numbers:

93284UIOO

Product: 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

Lot Numbers:

84347UN18

Product: 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

Lot Numbers:

18004181

Product: 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

Lot Numbers:

18005182

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82590

Status: Resolved

Manufacturer: Abbott Laboratories

Manufactured In: United States

Units Affected: 9 products (1 unit; 1 unit; 1 unit; 2 units; 2 units; 3 units; 1 unit; 1 unit; 1 unit)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

LN 1L76-01; Lot 46K15718

Lot Numbers:

46K15718

LN 4P72-01; Lot 902920500

Lot Numbers:

902920500

LN 8K25-12; Lot 01018I000

Lot Numbers:

01018I000

LN 8K25-04; Lot 01018H000

Lot Numbers:

01018H000

LN 3P25-11; Lot 94347UIOO

Lot Numbers:

94347UIOO

LN 3P25-02; Lot 93284UIOO

Lot Numbers:

93284UIOO

LN 09P3501; Lot 84347UN18

Lot Numbers:

84347UN18

LN 5P78-10; Lot 18004181

Lot Numbers:

18004181

LN 5P78-11; Lot 18005182

Lot Numbers:

18005182