CLASS II ONGOING Device recall · Reported 11 Jun 2025 · FDA Enforcement Report
Access Testosterone assay recalled by Beckman Coulter
Beckman Coulter is recalling Access Testosterone assay, distributed in Florida. The recall was initiated on 5 May 2025 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-1901-2025
- FDA event ID
- 96824
- Recalling firm
- Beckman Coulter, Chaska, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 May 2025
- FDA classified
- 2 Jun 2025
- Reported
- 11 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 5 May 2025 | Recall initiated by company | |
| 2 Jun 2025 | Classified by FDA | +28 days |
| 11 Jun 2025 | 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
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.
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
Access Testosterone assay, Catalog Number 33560
Where it was distributed
US State: FL. UAE, Vietnam
Questions about this recall
Why was it recalled?
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.
Which lots are affected?
UDI-DI: 15099590231347; Serial Number: 538081
Where was it sold?
US State: FL. UAE, 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.
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|---|---|---|---|---|---|
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| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
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| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
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| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
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