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AST (SGOT) Reagent Set

CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Model R1 x 500mL, R2 x 125mL · UDI-DI 00812137011886

510(k) clearances

Adverse events

Recalls

Facilities

Description

For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. AST is widely distributed in tissues with the highest concentrations found in the liver, heart, skeletal muscle and kidneys. Diseases involving any of these tissues can lead to elevated levels of AST in serum. Following myocardial infarction, AST levels are elevated and reach a peak after 48 to 60 hours. Hepatobiliary diseases such as cirrhosis, metastatic carcinoma and viral hepatitis can show increased levels of AST. Other disorders which can lead to an elevated level of AST are muscular dystrophy, dermatomyositis, acute pancreatitis and infectious mononucleosis.

Recalls

Date	Firm	Reason
2023-09-06	Randox Laboratories Ltd.	RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may
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
2014-08-11	ELITech Clinical Systems SAS	Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.
2014-03-05	Alfa Wassermann, Inc.	Extremely low absorbance readings.
2013-06-12	Ortho-Clinical Diagnostics	Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
2012-10-10	Horiba Instruments, Inc dba Horiba Medical	Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two
2012-02-15	Medtest Holdings, Inc.	A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, whi
2008-08-25	Pointe Scientific, Inc.	The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.
2008-08-25	Pointe Scientific, Inc.	The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.

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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.