CLASS II Device recall · Reported 9 Oct 2019 · FDA Enforcement Report
The Access Cortisol Reagent recalled by Beckman Coulter
Beckman Coulter is recalling The Access Cortisol Reagent, distributed nationwide in the US. The recall was initiated on 18 Sep 2018 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-2763-2019
- FDA event ID
- 83163
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Sep 2018
- FDA classified
- 30 Sep 2019
- Reported
- 9 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 18 Sep 2018 | Recall initiated by company | |
| 30 Sep 2019 | Classified by FDA | +377 days |
| 9 Oct 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%).
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Lithuania, Mexico, Panama, Serbia, South Africa, and Vietnam.
Questions about this recall
Is The Access Cortisol Reagent recalled?
Yes. Beckman Coulter recalled The Access Cortisol Reagent on 18 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-2763-2019.
Why was it recalled?
Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%).
Which lots are affected?
Lot Number 831755.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Lithuania, Mexico, Panama, Serbia, South Africa, 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Beckman Coulter
All 334| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 | 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) on recalled | Beckman Coulter | Other | Nationwide |
| Device | CLASS II | Access Total T4 Calibrator recalled by Beckman Coulter | Beckman Coulter | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S 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 | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |