REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest
Summary
The FDA issued a Class II for REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD by Cellavision AB. Reason: Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic resul.
Details
Source
Device Recall
External ID
Z-0542-2026
Action Date
2025-11-26
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: UDI: 0735004097202/ Serial Numbers 63220-70093 or CN63220-CN70093 Serial Numbers 60001-63219 or CN60001-CN63219
Quantity Affected: 688 units
Reason for Recall
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
Distribution
US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-08
Company
Lund
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 222 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cellavision AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cellavision AB have FDA actions?
This is the only FDA action we have on record for Cellavision AB in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0542-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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