Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported June 20, 2018
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
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 slide…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cellavision Ab recalled CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: Cell… - a moderate-severity action.
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: Cell… was recalled by Cellavision Ab in June 20, 2018. Reason: A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent …. Check the official notice for the remedy. Verify recall #Z-2184-2018 with the FDA Devices before acting.
The recall
Cellavision Ab issued this moderate-severity FDA Devices recall-A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent ….
- Moderate
- severity level
- Class II
- classification
- June 20, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2184-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2184-2018) was formally reported on June 20, 2018, with the manufacturer initiating the action on December 4, 2017. It is classified under Moderate severity (Class II), with a current status of Ongoing. Cellavision Ab is listed as the recalling firm, operating out of Lund, N/A. Federal records list the affected scope as Instruments: 224 Software: 99 (US).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Nationwide in the states of FL, IL, NY, and NC. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Instruments: 224 Software: 99 (US)
Related Recalls
6
3 from same agency
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2184-2018 |
| Date reported | June 20, 2018 |
| Date initiated | December 4, 2017 |
| Recalling firm | Cellavision Ab |
| Firm location | Lund, N/A |
| Affected scope | Instruments: 224 Software: 99 (US) |
| Distribution | US Nationwide in the states of FL, IL, NY, and NC |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2184-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cellavision Ab. Units affected: Instruments: 224 Software: 99 (US).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on June 20, 2018. Severity: Moderate. Recall number: Z-2184-2018.
Where was the recalled product distributed? ▼
Distribution: US Nationwide in the states of FL, IL, NY, and NC.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2184-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 20, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.