CLASS II Device recall · Reported 18 Nov 2015 · FDA Enforcement Report
Access CEA Assay recalled by Beckman Coulter
Beckman Coulter is recalling Access CEA Assay, distributed nationwide in the US. The recall was initiated on 13 Oct 2015 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-0239-2016
- FDA event ID
- 72408
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Oct 2015
- FDA classified
- 6 Nov 2015
- Reported
- 18 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Oct 2015 | Recall initiated by company | |
| 6 Nov 2015 | Classified by FDA | +24 days |
| 18 Nov 2015 | 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 is recalling the Access CEA reagent packs because they were filled incorrectly.
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 CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Where it was distributed
Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Egypt, France, Germany, Ghana, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Mexico, Morocco, Myanmar, Netherlands, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.
Questions about this recall
Is Access CEA Assay recalled?
Yes. Beckman Coulter recalled Access CEA Assay on 13 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0239-2016.
Why was it recalled?
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
Which lots are affected?
595027 595029
Where was it sold?
Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Egypt, France, Germany, Ghana, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Mexico, Morocco, Myanmar, Netherlands, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, 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.
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