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Abbott Molecular, Inc.

Abbott Molecular, Inc. Recalls

All product recalls associated with Abbott Molecular, Inc..

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Recall Summary

Total Recalls

1000

Past Year

295

Class I (Serious)

116

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1221–1240 of 4465 recalls

Abbott Molecular, Inc.: Vysis CLL FISH Probe Kit with the following components: V...

Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.

FDAAug 4, 2021Nationwide• Abbott Molecular, Inc.

Raw Shelled Peanuts (OLAM) – Metal Object Contamination (2021)

Firm was notified of metal objects in the product.

Class IIModerate

FDAAug 4, 2021GA, IL• OLAM Edible Nuts-Blakely,GA

Antigua Carretera Sanchez Itabo, Haina Dominican Republic (the): Arjo Disposable Repositioning Sling, Model AHD001

Sling loop straps on device pose a trip hazard.

FDAJul 30, 2021Nationwide

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• Antigua Carretera Sanchez Itabo, Haina Dominican Republic (the)

Succinylcholine Chloride (BayCare) – Sterility Risk (2021)

Lack of sterility assurance

Class IIModerate

FDAJul 30, 2021FL• BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy

GaviLyte-C (Lupin) – Osmolarity Specification (2021)

Failed Stability Specification; Out of specification for Osmolarity

Class IIModerate

FDAJul 29, 2021Nationwide• Novel Laboratories, Inc. d.b.a LUPIN

Pimento Cheese Sandwich (Modern Vending) – undeclared fish (2021)

Fish not declared as an allergen

Class IIModerate

FDAJul 27, 2021KY• Modern Distributors, Inc. dba Modern Vending

Abbott Laboratories: Alinity ci-series System Control Module clinical chemistr...

Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sample processing. 2) Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3) A sample exception with message code 150 "Unable to process test. Previous processing module error" is produced without notifying the operator of a reagent pipettor failure and may cause processing module to transition into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. 4. Reagent short dispense: Alinity c needs a control measure to protect against the potential for short reagent dispense. Addition of a maximum depth limit for reagent cartridges on the Alinity c to prevent the potential for a short dispense is needed. 5. RSM indicators were blinking green incorrectly: The Reagent and Sample Manager (RSM) indicators will incorrectly blink green indicating that processing is completed and the rack or cartridge can be removed from the loading area when the rack or cartridge should not be accessed. 6. Erroneous ICT Calibration Curves: Erroneous ICT calibration curves might be generated for the Alinity c when there is a malfunction of ICT reference solution delivery, use of wrong/evaporated calibrator, defective ICT modules, etc.

FDAJul 26, 2021Nationwide• Abbott Laboratories

Becton, Dickinson and Company, BD Biosciences: BD" Mouse IgG2a Isotype Control APC X39 ASR

Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody.

FDAJul 22, 2021Nationwide• Becton, Dickinson and Company, BD Biosciences

Trophy SAS Trophy Sas Trophy; Croissy Beaubourg: CS9600isanextraoralsystemintendedtoproducetwo-dimensional...

Device failed to function as intended and/or failed to conform to their design specifications.

FDAJul 21, 2021Nationwide• Trophy SAS Trophy Sas Trophy; Croissy Beaubourg

2022 THOMAS BUILT BUSES SAF-T-LINER C2 Recall: PARKING BRAKE:ELECTRICAL:SWITCH

Daimler Trucks North America, LLC (DTNA) is recalling certain 2021-2022 Thomas Built C2 Saf-T-Liner school buses. The parking brake activation switch may fail to set the parking brake.

NHTSAJul 20, 2021Nationwide• THOMAS BUILT BUSES

Choujuki White Bread (Blue Robins) – Undeclared Milk (2021)

Internal label review found that their labeling did not properly declare milk (sub ingredient of margarine) or as an allergen

Class IIModerate

FDAJul 15, 2021CA• BLUE ROBINS INC

Abbott Laboratories, Inc: Alinity s System REF 06P16-01. An automated immunoassay...

A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.

FDAJul 12, 2021Nationwide• Abbott Laboratories, Inc

PROCEPT BIOROBOTICS CORPORATION: AQUABEAM Handpiece, REF: HP2000, a sterile single-use com...

Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay for handpiece exchange. Tip detachment can be seen cystoscopically and tip separation from the handpiece may necessitate tip removal from the bladder or prostate.

FDAJul 9, 2021Nationwide• PROCEPT BIOROBOTICS CORPORATION

Laboratoires Bodycad, Inc.: Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203...

There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.

FDAJul 2, 2021CO, MI, NY• Laboratoires Bodycad, Inc.

Caribbean Rub (Caribbean Belize) – Undeclared Wheat (2021)

Undeclared Allergen

Undeclared Wheat Allergen

Class IIModerate

FDAJul 2, 2021CA, IL, IA +3 more• Caribbean Belize LLC

Gibson Bioscience: Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potas...

A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.

FDAJul 1, 2021CA, CO, KY +4 more• Gibson Bioscience

B. Braun Medical, Inc.: Infusomat Space Volumetric Pump Administration Set, Produ...

There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.

FDAJun 25, 2021CA, MI, OR +1 more• B. Braun Medical, Inc.

2018 THOMAS BUILT BUSES SAF-T-LINER HDX Recall: SEATS

Daimler Trucks North America, LLC (DTNA) is recalling certain 2018-2022 Thomas Built Saf-T-Liner HDX School Buses. These school buses may have been manufactured with an incorrect passenger seat configuration that does not provide the proper amount of seat back protection. As such, these school buses fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 222, "School Bus Passenger Seating and Crash Protection."

NHTSAJun 17, 2021Nationwide• THOMAS BUILT BUSES

Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium: Proteus 235- designed to produce and deliver a proton bea...

Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

FDAJun 14, 2021Nationwide• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium

Abbott Laboratories: REF: 08P1820, Abbott Alinity c Activated Alanine Aminotr...

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 potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results.

FDAJun 10, 2021Nationwide• Abbott Laboratories