CLASS II Device recall · Reported 24 May 2017 · FDA Enforcement Report
Salicylate Reagent (SALY 2 x recalled by Beckman Coulter
Beckman Coulter is recalling Salicylate Reagent (SALY 2 x, distributed in Puerto Rico. The recall was initiated on 3 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2084-2017
- FDA event ID
- 76962
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Apr 2017
- FDA classified
- 12 May 2017
- Reported
- 24 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Apr 2017 | Recall initiated by company | |
| 12 May 2017 | Classified by FDA | +39 days |
| 24 May 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Product as listed by the FDA
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.
Where it was distributed
Worldwide Distribution -- Australia, Bangladesh, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, Egypt, Eritrea, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States including Puerto Rico, and Vietnam.
Questions about this recall
Why was it recalled?
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Which lots are affected?
all lots
Where was it sold?
Worldwide Distribution -- Australia, Bangladesh, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, Egypt, Eritrea, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States including Puerto Rico, and Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 76962This product is part of a recall event; the main page for the event is Enzymatic Creatinine Reagent (CR-E ) recalled by Beckman Coulter.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Enzymatic Creatinine Reagent (CR-E ) recalled by Beckman Coulter | Beckman Coulter | Other | PR | |
| CLASS II | HDL Cholesterol Reagent (HDL ) recalled by Beckman Coulter | Beckman Coulter | Other | PR | |
| CLASS II | Cholesterol Reagent(CHOL ) recalled by Beckman Coulter | Beckman Coulter | Other | PR | |
| CLASS II | Triglycerides Reagent (TG ) recalled by Beckman Coulter | Beckman Coulter | Other | PR | |
| CLASS II | Uric Acid Reagent (URIC ) recalled by Beckman Coulter | Beckman Coulter | Other | PR | |
| CLASS II | Lactate Reagent (LACT 2 x recalled by Beckman Coulter | Beckman Coulter | Other | PR |
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|---|---|---|---|---|---|
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
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| Device | CLASS II | REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US) recalled | Beckman Coulter | Other | Nationwide |
| Device | CLASS II | REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) recalled | Beckman Coulter | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |