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Pointe ALT for the BS480

HORIBA INSTRUMENTS INCORPORATED · Model 14-A7526-375 · UDI-DI 00811727015716

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510(k) clearances

Adverse events

Recalls

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Description

Pointe ALT packaged for the BS480 Analyzer. 5x60mL, 5x15mL Kit. For the quantitative determination of Alanine Aminotransferase in serum on the BS480 Analyzer.

Recalls

Date	Firm	Reason
2021-06-10	Abbott Laboratories	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 patie
2021-06-10	Abbott Laboratories	There is a potential for >10% 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 pati
2021-06-10	Abbott Laboratories	There is a potential for >10% 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 pati
2021-06-10	Abbott Laboratories	There is a potential for >10% 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 pati
2017-06-29	Siemens Healthcare Diagnostics, Inc.	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele
2017-06-29	Siemens Healthcare Diagnostics, Inc.	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele
2017-06-29	Siemens Healthcare Diagnostics, Inc.	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele
2016-07-20	Sterling Diagnostics, Inc.	Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
2014-03-05	Alfa Wassermann, Inc.	Extremely low absorbance readings.
2010-11-19	Abaxis, Incorporated	Abaxis has determined that during the manufacture of product lot 0396BC5 may report inaccurate values of Alanine Aminotransferase (ALT) when used in the Piccolo Blood Chemistry Ana

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.