CLASS II ONGOING Device recall · Reported 20 Jun 2018 · FDA Enforcement Report
CellaVision DM recalled by Cellavision AB
Cellavision AB is recalling CellaVision DM, distributed nationwide in the US. The recall was initiated on 4 Dec 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-2184-2018
- FDA event ID
- 80137
- Recalling firm
- Cellavision AB, Lund, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Dec 2017
- FDA classified
- 13 Jun 2018
- Reported
- 20 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 4 Dec 2017 | Recall initiated by company | |
| 13 Jun 2018 | Classified by FDA | +191 days |
| 20 Jun 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
Where it was distributed
US Nationwide in the states of FL, IL, NY, and NC
Questions about this recall
Is CellaVision DM recalled?
Yes. Cellavision AB recalled CellaVision DM on 4 Dec 2017. The recall is Class II and its status is Ongoing. Recall number Z-2184-2018.
Why was it recalled?
A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.
Which lots are affected?
Versions 6.0.1 or 6.0.2
Where was it sold?
US Nationwide in the states of FL, IL, NY, and NC
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 Cellavision AB
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer recalled | Cellavision AB | Other | Nationwide |
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