Manufacturer
31 recalls in our database name Abbott Point Of Care Inc. as the manufacturing or recalling firm.
Of the 31 recalls from Abbott Point Of Care Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Abbott Point Of Care is recalling approximately 7.6% of specific i-STAT EG7+ cartridge lots due to a manufacturing issue causing falsely high pCO2 and low pH readings. Inaccurate results could lead clinicians to make unnecessary or harmful medical interventions.
Abbott is recalling certain i-STAT EG6+, EG7+, and G3+ blood gas cartridges that may report falsely high CO2 and falsely low pH results due to a manufacturing issue, potentially leading to unnecessary or harmful clinical interventions.
Abbott Point Of Care Inc. is recalling approximately 7.6% of i-STAT G3+, i-STAT EG6+, and i-STAT EG7+ blood gas cartridges due to a manufacturing issue causing falsely high PCO2 and low pH readings, which may lead to unnecessary or harmful clinical interventions.
i-STAT CG8+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 8,962,450 units are affected.
i-STAT EG7+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 6,115,950 units are affected.
i-STAT CG4+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting the updated lactate sample type and pH and PO2 measurement ranges. 9,067,050 units are affected.
i-STAT EG6+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 547,250 units are affected.
Abbott Point Of Care Inc. is recalling i-STAT EG7+ cartridges because the ionized calcium test may report higher than expected results if stored at room temperature for specific periods.
Abbott is recalling i-STAT CG8+ cartridges because the ionized calcium test may report higher than expected results if stored at room temperature for specific periods.
Abbott Point Of Care Inc. is recalling i-STAT CHEM8+ cartridges because they are not FDA cleared and do not have CLIA waived status.
Abbott Point Of Care Inc. is recalling i-STAT CG4+ cartridges because they are not FDA cleared and lack CLIA waived status.
Abbott Point of Care is recalling i-STAT G3+ blue cartridges because it lacks sufficient clinical evidence to characterize their performance.
Abbott Point Of Care Inc. is recalling i-STAT cTnI cartridges because they may generate a higher than expected number of quality check codes.
Abbott Point Of Care Inc. is recalling i-STAT CG8+ Cartridges because they may generate inaccurate potassium results, potentially leading to incorrect clinical decisions.
Abbott Point Of Care Inc. is recalling 894 i-STAT DE handheld data processing modules because a software upgrade resets customized settings and prevents certain data from updating.
Abbott Point Of Care Inc. is recalling specific lots of i-Stat PT/INR Cartridges because they may generate excessive star outs, potentially delaying patient results.
Abbott Point of Care is recalling i-STAT G3+ Cartridges (Lot N13183) because they may produce incorrectly elevated PCO2 and depressed pH results.
Abbott Point of Care Inc. is recalling i-STAT PT/INR cartridges because they may display incorrectly elevated INR results.
Abbott Point of Care is recalling specific lots of Cliniqa Liquid QC Cardiac Marker Control for i-STAT because results may be generated below the lower value assignment range.
Abbott Point of Care is recalling i-STAT cTnI cartridges because they may produce incorrectly elevated cardiac troponin I results.
Abbott Point of Care Inc. is recalling i-Stat BNP cartridges because atmospheric pressure can cause suppressed test results, potentially affecting heart failure diagnosis.
Abbott Point of Care Inc. is recalling i-Stat CK-MP cartridges because atmospheric pressure can cause suppressed test results, potentially affecting the diagnosis of myocardial infarction.
Abbott Point of Care Inc. is recalling i-STAT PT/INR cartridges because they may display incorrectly elevated results, potentially affecting monitoring of patients on anticoagulation therapy.
Abbott Point of Care Inc. is recalling i-Stat cTnl cartridges because atmospheric pressure affects the frequency of suppressed results.
Abbott Point of Care is recalling 52,750 i-Stat EG7 cartridges because they may produce falsely low PCO2 readings if stored at room temperature for four weeks or longer.