FDA (Devices) recall action 82590

Abbott Laboratories recalled 9 products on 2019-05-22

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2019-05-22
Critical: 0
Units: 13

Why these products were recalled

Devices were delivered without the required dry ice.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–9 of 9

LowFDA (Devices)··2019-05-22
Abbott Recalls Alinity i Anti-TPO Calibrators Due to Missing Dry Ice
Abbott Laboratories is recalling Alinity i Anti-TPO Calibrators in Latvia because they were delivered without required dry ice.
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.
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Distribution
0 states
LowFDA (Devices)··2019-05-22
Abbott Technopath Multichem S Plus Level 2 Recalled for Missing Dry Ice
Abbott Laboratories is recalling Technopath Multichem S Plus Level 2 quality control serum delivered to Latvia without required dry ice.
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.
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Distribution
0 states
LowFDA (Devices)··2019-05-22
Abbott Troponin-I Calibrators Recalled for Missing Dry Ice Packaging
Abbott Laboratories is recalling ARCHITECT STAT High Sensitive Troponin-I Calibrators because they were delivered without the required dry ice.
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
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Distribution
0 states
LowFDA (Devices)··2019-05-22
Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Missing Dry Ice
Abbott Laboratories is recalling two units of ARCHITECT Intact PTH Calibrators because they were delivered without the required dry ice.
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.
Category
Distribution
0 states
LowFDA (Devices)··2019-05-22
Abbott Recalls ARCHITECT Sirolimus Calibrators Shipped Without Dry Ice
Abbott Laboratories is recalling ARCHITECT Sirolimus Calibrators in Latvia because they were delivered without the required dry ice.
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.
Category
Distribution
0 states
LowFDA (Devices)··2019-05-22
Abbott Troponin-I Controls Recalled for Missing Dry Ice
Abbott Laboratories is recalling ARCHITECT STAT High Sensitive Troponin-I Controls delivered without required dry ice to Latvia.
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 use
Category
Distribution
0 states
LowFDA (Devices)··2019-05-22
Abbott Multichem S Plus Quality Control Serum Recalled for Missing Dry Ice
Abbott Laboratories is recalling Technopath Multichem S Plus Level 1 quality control serum because units were delivered without required dry ice.
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.
Category
Distribution
0 states
LowFDA (Devices)··2019-05-22
Abbott Recalls ARCHITECT HbA1C Calibrators Shipped Without Dry Ice
Abbott Laboratories is recalling ARCHITECT HbA1C Calibrators in Latvia because they were delivered without the required dry ice.
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.
Category
Distribution
0 states
LowFDA (Devices)··2019-05-22
Abbott Recalls ARCHITECT Intact PTH Controls Due to Missing Dry Ice
Abbott Laboratories is recalling ARCHITECT Intact PTH Controls because they were delivered without required dry ice. The recall affects units distributed to Latvia.
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.
Category
Distribution
0 states