CLASS II Device recall · Reported 12 Jul 2017 · FDA Enforcement Report
Coulter PrepPlus recalled by Beckman Coulter
Beckman Coulter is recalling Coulter PrepPlus. The recall was initiated on 22 May 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-2689-2017
- FDA event ID
- 77362
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 May 2017
- FDA classified
- 6 Jul 2017
- Reported
- 12 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 22 May 2017 | Recall initiated by company | |
| 6 Jul 2017 | Classified by FDA | +45 days |
| 12 Jul 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
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
Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Where it was distributed
Worldwide Distribution
Questions about this recall
Is Coulter PrepPlus recalled?
Yes. Beckman Coulter recalled Coulter PrepPlus on 22 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2689-2017.
Why was it recalled?
When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
Which lots are affected?
All serial numbers currently in the field
Where was it sold?
Worldwide Distribution
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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