Siemens Healthcare ALT Reagent Assays May Give False Drug Results
Siemens Healthcare recalls ALT reagent assays that may cause false high or low drug results for sulfasalazine and sulfapyridine. Affected products include specific part numbers sold by Randox Laboratories.
Lower-risk 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.
Contact the company
What happened, in plain English
Siemens Healthcare recalls ALT reagent assays that can give false results for sulfasalazine and sulfapyridine drugs. This could lead to incorrect medical decisions if used in blood tests. Read more at govinfonow.com/recall/73498-siemens-healthcare-alt-reagent-assays-may-give-false-drug-results.
Source Summary by GovInfoNow · govinfonow.com/recall/73498-siemens-healthcare-alt-reagent-assays-may-give-false-drug-results · Updated September 20, 2026 · FDA enforcement record: FDA #Z-1647-2018
Cite this page
“Siemens Healthcare ALT Reagent Assays May Give False Drug Results.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73498-siemens-healthcare-alt-reagent-assays-may-give-false-drug-results. Based on FDA recall #Z-1647-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1647-2018%22&limit=1).
Why it’s dangerous
The reagent assays can interfere with blood tests for sulfasalazine and sulfapyridine, causing false high or low results. This might lead to incorrect medical decisions if the test results are used.
Who’s affected
People using blood tests for sulfasalazine or sulfapyridine treatments may be affected. Those with these medications are most at risk.
How to tell if you have this one
Check for product numbers 10318168, 10309500, 10283341, or 10283342. These reagents were sold by Randox Laboratories and are used for ALT blood tests.
- Brand
Siemens Healthcare- Category
Medical device
All 17 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico. Distributed in 108 foreign countries: Afghanistan Bolivia Albania¿¿¿¿¿¿¿¿ Algeria¿¿¿¿¿¿¿¿ Angola ARGENTINA Armenia AUSTRALIA Austria¿¿¿¿¿¿¿¿ Azerbaijan Bahamas Bahrain¿¿¿¿¿¿¿¿ Bangladesh¿¿¿¿¿ Belarus¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil Bulgaria¿¿¿¿¿¿¿ Cambodia Canada Canary islands Chile China Colombia Costa Rica Croatia¿¿¿¿¿¿¿¿ Cyprus¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Ecuador Egypt¿¿¿¿¿¿¿¿¿¿ El Salavador Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Guatemala Honduras Hong Kong Hungary¿¿¿¿¿¿¿¿ Iceland India Indonesia Iraq Ireland¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ japan Jordan Kazakhstan¿¿¿¿¿ Korea Kuwait Latvia¿¿¿¿¿¿¿¿¿ Lebanon Lithuania¿¿¿¿¿¿ Luxembourg¿¿¿¿¿ Macedonia Malaysia Mali Malta¿¿¿¿¿¿¿¿¿¿ Mexico Morocco¿¿¿¿¿¿¿¿ Myanmar Nepal Netherlands¿¿¿¿ New Zealand Nicaragua Norway¿¿¿¿¿¿¿¿¿ Oman Pakistan¿¿¿¿¿¿¿ Paraguay Peru Philippines Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Qatar¿¿¿¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Russian¿Fed.¿¿¿ Saudi Arabia Senegal Serbia¿¿¿¿¿¿¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Singapore Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ South Africa South Africa South Korea Spain¿¿¿¿¿¿¿¿¿¿ Sri Lanka Sweden¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Taiwan¿¿¿¿¿¿¿¿¿ Tajikistan Thailand Tunisia¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ Turkmenistan¿¿¿ United Arab Emerites¿¿¿¿¿¿ United¿Kingdom¿ Uruguay¿¿¿¿¿¿¿¿ Uzbekistan Vatikancity¿¿¿¿ Venezuela Vietnam Yemen
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1646-2018 | ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories); All lots | 7014 |
| Z-1647-2018 | 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); All lots | 33,233 |
| Z-1648-2018 | ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics); All lots | 1667 |
| Z-1649-2018 | Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 37,923 |
| Z-1650-2018 | Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 276,511 |
| Z-1651-2018 | Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 181,072 |
| Z-1652-2018 | Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 80,466 |
| Z-1653-2018 | Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 30,446 |
| Z-1654-2018 | Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 10,056 |
| Z-1655-2018 | Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 34,590 |
| Z-1656-2018 | Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 109,334 |
| Z-1657-2018 | Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 32,744 |
| Z-1658-2018 | Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 19,245 |
| Z-1659-2018 | Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 3130 |
| Z-1660-2018 | Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 19,991 |
| Z-1661-2018 | Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 10,067 |
| Z-1662-2018 | Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE); All lots | 226 |
What to do — step by step
Check Product Numbers
Look for product numbers 10318168, 10309500, 10283341, or 10283342 on the reagent packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico. Distributed in 108 foreign countries: Afghanistan Bolivia Albania¿¿¿¿¿¿¿¿ Algeria¿¿¿¿¿¿¿¿ Angola ARGENTINA Armenia AUSTRALIA Austria¿¿¿¿¿¿¿¿ Azerbaijan…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these reagents?
No, but you should check if you have the affected product numbers. The recall does not require immediate stop use.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1647-2018 (June 29, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1647-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.