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ALT (SGPT) KINETIC METHOD TC MATRIX-240/480
TECO DIAGNOSTICS · Model A524-780 · UDI-DI 10673486001099
CKA
Prescription
10
510(k) clearances
92
Adverse events
18
Recalls
44
Facilities
Description
The ALT (SGPT) KINETIC METHOD TC MATRIX-240/480 is used for the quantitative determination of alanine aminotransferase in serum used in routine examination and monitoring of therapy and relapses.
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 |
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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.