Devices

Device Recall Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set

Model / Serial
list 05J83-001, part number 32-191025, lot numbers 79500, exp. 8-9-08 and 80178, exp.10-16-08
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide including USA, Austria, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, and the United Kingdom.
Product Description
Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; || The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.
Manufacturer
Abbott Molecular
1 Event
- Recall of Device Recall Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set

Manufacturer

Abbott Molecular

Manufacturer Address
Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018-3315
Source
USFDA

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