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Abbott Point of Care Inc.

Abbott Point of Care Inc. Recalls

All product recalls associated with Abbott Point of Care 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 3921–3940 of 4465 recalls

Abbott Point of Care Inc.: Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu); ...

Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

FDAOct 18, 2007Nationwide• Abbott Point of Care Inc.

PML, Inc. dba Pml Microbiologicals Inc.: PML --IDS Rapid NH QC Set- Quality Control kit for cultur...

Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901).

FDAOct 15, 2007Nationwide• PML, Inc. dba Pml Microbiologicals Inc.

PML, Inc. dba Pml Microbiologicals Inc.: PML -- LyfoCults Haemophilus parainfluenzae - micro organ...

Incorrect micro-organism-- Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901).

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FDAOct 15, 2007Nationwide• PML, Inc. dba Pml Microbiologicals Inc.

PML, Inc. dba Pml Microbiologicals Inc.: PML -- Vitek NH ID Card (NHI) Set - Quality Control kit ...

Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901).

FDAOct 15, 2007Nationwide• PML, Inc. dba Pml Microbiologicals Inc.

Boston Scientific Corporation One Boston: Boston Scientific, Imager II Angiographic Catheter, (Oute...

Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.

FDAOct 12, 2007AZ, CA, NJ +1 more• Boston Scientific Corporation One Boston

Abbott Laboratories Inc.: Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-...

Three potential issues with Creatine Kinase Lot Number: 52044HW00: (1) Decrease in quality control and/or patient results (2) An iIncreased imprecision, or (3) Error Code 1054 (Unable to calculate results, Reaction Failure) on Architect cSystems.

FDAOct 12, 2007Nationwide• Abbott Laboratories Inc.

Abbott Laboratories, Inc: Abbott ACCELERATOR APS System Input/Output Module (IOM); ...

Sample problems; Five issues identified related to software utilized by the ACCELERATOR APS System Input/Output Module, to include: Under three specific conditions, the post-aspiration radio-frequency identification (RF ID) read of the tube carrier is not performed and the APS work cell may not appropriately generate Sample Presentation/Sample Queue errors with APS software version 1.1.1 or earlie

FDAOct 10, 2007Nationwide• Abbott Laboratories, Inc

BD Biosciences: BD FACS Sample Prep Assistant II, Part Number: 337170; Pr...

Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.

FDAOct 2, 2007AZ, IL, MN +4 more• BD Biosciences

Abbott Laboratories: Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 te...

Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components, which could result in both false reactive and false nonreactive specimens.

FDAOct 1, 2007Nationwide• Abbott Laboratories

Abbott Laboratories, Inc: Clinical Chemistry ICT Calibrator, List Number: 1E46-02, ...

Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected. The investigation determined that the interferent affects Potassium (K+) only. Use of the affected calibrator vials will generate an acceptable, but low calibration slope. When Quality Control (QC) is run to verify the calibration, K+ QC results may be bel

FDASep 26, 2007PR• Abbott Laboratories, Inc

Bio-Rad Labroatories Inc.: BioPlex 2200 System, Cat. No. 665-1460A containing APF CD...

Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive)

FDASep 25, 2007Nationwide• Bio-Rad Labroatories Inc.

Single Post Swing Sets (BCI Burke) – Fall Hazard (2007)

The recall includes the Single Post Swing Set (model 550-0033) and added bay swings (model 550-0035) with belt or bucket seats. The swings are made with a 2-3/8-inch diameter top beam that is welded to a formed plate on each end to attach to the upright post.

CPSCSep 25, 2007Nationwide• BCI Burke Company LLC, of Fond du Lac, Wisc.

Abbott Laboratories: ARCHITECT i System Assay CD-ROM - WW (excluding USA accou...

The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP assay file for the ARCHITECT AFP non-U.S. product. The assay labeling indicates that the limit flag should be set no lower than 20 ng/mL

FDASep 18, 2007Nationwide• Abbott Laboratories

Gambro BCT, Inc.: Spectra Optia apheresis system, a blood component separat...

Under specific conditions, apheresis machine could return up to 60mL of air to the patient.

FDASep 18, 2007Nationwide• Gambro BCT, Inc.

Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342: HiRes 90K devices with Helix Electrodes Model CI 1400-02H...

Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.

FDASep 14, 2007Nationwide• Advanced Bionics Corporation 12740 San Fernando Rd Bldgs. 1 & 3 Sylmar CA 91342

BD Biosciences, Systems & Reagents: CellQuest Pro SW, version 4.0.2. and later; Becton Dickin...

Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.

FDASep 7, 2007Nationwide• BD Biosciences, Systems & Reagents

BD Biosciences: BD Biosciences MultiSET Flow Cytometry Software Versions ...

Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.

FDASep 6, 2007PR• BD Biosciences

BD Diagnostic Systems Lee Laboratories: BD DifcoTM Neisseria Meningitidis Antisera Group Y, 2288...

Exhibits cross reactivity with Neisseria meningitides Group W135.

FDASep 6, 2007Nationwide• BD Diagnostic Systems Lee Laboratories

Bio-Rad Laboratories: Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in...

Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.

FDASep 5, 2007Nationwide• Bio-Rad Laboratories

Abbott Laboratories, Inc: ARCHITECT c16000 Processing Module, for In Vitro Diagnost...

Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT cSystem Software, test results may be incorrectly associated to a Sample Identification during specific sample-processing conditions of the Robotic Sample Handler.

FDASep 5, 2007PR• Abbott Laboratories, Inc