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Pointe Scientific, Inc. ALT

HORIBA INSTRUMENTS INCORPORATED · Model OA926-487 · UDI-DI 00811727014917

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Pointe Scientific, Inc. ALT Reagent is for the quantitative determination of Alanine Aminotransferase in serum. Packaged with barcodes for use on AU400, AU480 and AU640. 6 x 67ml, 5 x 17ml.

Recalls

Date	Firm	Reason
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
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
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.