Electrode, Ion-specific, Chloride

OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box).

The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma.

OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care.

Outer box labeling shows an incorrect storage temperature range.

ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, v2.20DB, v2.60, v3.10, 3.11 and 3.12; d

Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample.

Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064

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

D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer.

The CI membrane units generate too low values for status and sensitivity during calibration.

ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laborator

Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during use.

VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

Abbott ARCHITECT cSystems ICT Module, REF 09D28-03.

There is a potential to generate falsely elevated serum or plasma chloride results when using the product.

VITROS Chemistry Products Cl- Slides, Product Code 844 5207

The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.