CLASS II Device recall · Reported 26 Feb 2014 · FDA Enforcement Report
UniCel DxI 600 Access Immunoassay System Analyzer recalled
Beckman Coulter is recalling UniCel DxI 600 Access Immunoassay System Analyzer, distributed in South Dakota. The recall was initiated on 26 Nov 2013 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-0985-2014
- FDA event ID
- 66958
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Nov 2013
- FDA classified
- 16 Feb 2014
- Reported
- 26 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Nov 2013 | Recall initiated by company | |
| 16 Feb 2014 | Classified by FDA | +82 days |
| 26 Feb 2014 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect 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
UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Where it was distributed
Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
Questions about this recall
Why was it recalled?
The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.
Which lots are affected?
Part Number A30260. Serial Numbers 900781.
Where was it sold?
Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
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
1 other product · FDA event 66958| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Access 2 Immunoassay System Analyzer recalled by Beckman Coulter | Beckman Coulter | Potency & Assay | SD |
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|---|---|---|---|---|---|
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