Home › HORIBA INSTRUMENTS INCORPORATED › Pointe Scientific
Pointe Scientific
HORIBA INSTRUMENTS INCORPORATED · Model HA926-504 · UDI-DI 00811727012883
CKA
Prescription
10
510(k) clearances
93
Adverse events
18
Recalls
44
Facilities
Description
ALT reagent for the quantitative determination of alanine aminotransferase in serum on Hitachi analyzers. For in vitro diagnostic use only. 6 x 67ml, 6 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 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 |
| 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.