Cell morphology analyzers recalled over barcodes read from the previous slide
Cellavision is recalling 688 DI-60 automated digital cell morphology analyzers because the barcode reader may read the previous slide's barcode, misattributing diagnostic results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: misattributed diagnostic results can be applied to the wrong patient, and no injuries are reported.
Plain-English summary
The Cellavision Automated Digital Cell Morphology analyzer DI-60, REF CC286297 or BS737162, used with a Honeywell Vuquest or Jadk FM-5 barcode reader component, is being recalled.
The automated cell-locating device barcode reader may read the barcode of the previously processed slide, resulting in a misattribution of diagnostic results.
The recall covers 688 units carrying UDI 0735004097202, across the listed serial number ranges. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
A result attached to the wrong patient's slide can inform decisions about the wrong person. Laboratories operating an affected analyzer should follow Cellavision's instructions.
The recalled product
- Product
- REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
- Manufacturer
- Cellavision AB
- Affected units
- 688
Distribution
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