Recall Z-1647-2018— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2017-06-29, terminated 2020-04-23. FDA's recall record names no specific 510(k) clearance for this event. Product: ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. (Product Numbers: 10318168, 10309500), ALT P5P (Part Numbers: 10318168/10326245, 10309500/10315181), and ALT Concentrated (Part Numbers: 10283341, 10283341, 10283342); (Mfr: Randox Laboratories). Reason: 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 elevated or falsely depressed results..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-29
- Terminated
- 2020-04-23
- Firm location
- Tarrytown, NY, United States
Product description
ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. (Product Numbers: 10318168, 10309500), ALT P5P (Part Numbers: 10318168/10326245, 10309500/10315181), and ALT Concentrated (Part Numbers: 10283341, 10283341, 10283342); (Mfr: Randox Laboratories)
Reason for recall
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 elevated or falsely depressed results.
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