Recall archive
73 recalls · page 2 of 4
Reported Aug 11, 2021
REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product · Product details — There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 23, 2021
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories Inc. (St Jude Medical)
Matched: Brand — Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 19, 2021
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories Inc. (St Jude Medical)
Matched: Brand — Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a…
FDA (openFDA device enforcement)
Reported Jul 22, 2020
Similac Pro-Advance Infant Formula with Iron, Milk-Based, Ready to Feed, 32 FL OZ (1 QT)
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Abbott Nutrition, Division
Matched: Brand — Water filled bottles labeled as Similac Pro-Advance.
FDA (openFDA food enforcement)
Reported Jun 10, 2020
Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product details — In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the…
FDA (openFDA device enforcement)
Reported May 13, 2020
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Abbott Laboratories
Matched: Brand — Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 15, 2020
ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand — Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent…
FDA (openFDA device enforcement)
Reported Apr 15, 2020
"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance…
FDA (openFDA device enforcement)
Reported Oct 30, 2019
Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product details — The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely…
FDA (openFDA device enforcement)
Reported Oct 16, 2019
Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product · Product details — Off color and odor. Compromised can seam due to product (powder) in the seam, this poor seal potentially allowed air into the container.
FDA (openFDA food enforcement)
Reported Oct 2, 2019
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand — The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the…
FDA (openFDA device enforcement)
Reported Sep 18, 2019
Similac Pro-Sensitive, 2 fl. oz. plastic bottles packed 12 per carton.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Nutrition, Division
Matched: Brand — a limited number of Similac Pro-Advance 2oz. Ready to Feed (RTF) bottles from a single batch were packaged in Similac Pro-Sensitive cartons.
FDA (openFDA food enforcement)
Reported Jul 31, 2019
C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand — An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2019
ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Abbott Laboratories
Matched: Brand — Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2019
TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories Inc. (St Jude Medical)
Matched: Brand — In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents…
FDA (openFDA device enforcement)
Reported May 22, 2019
ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Abbott Laboratories
Matched: Brand — Devices were delivered without the required dry ice.
8 more products in this recall
FDA (openFDA device enforcement)
Reported May 15, 2019
Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand · Product · Product details — There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
FDA (openFDA device enforcement)
Reported Apr 17, 2019
Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand · Product · Product details — There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 10, 2019
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand · Product · Product details — The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 10, 2019
CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product details — There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
FDA (openFDA device enforcement)
Reported Mar 13, 2019
ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand · Reason for recall — Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail…
FDA (openFDA device enforcement)
Reported Aug 1, 2018
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand · Reason for recall — Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model…
FDA (openFDA device enforcement)
Reported Mar 14, 2018
ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand · Product details — There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 29, 2017
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand — The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with…
1 more product in this recall
FDA (openFDA device enforcement)
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