Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096
Hazard
In Vitro diagnostic test kit may produce false positive patient results
What You Should Do
Remedy
The firm notified consignees by phone and fax 2/7/03 and advised of potential for false positive patient results. Firms were instructed to destroy remaining inventory for replacement. Consignees were asked to return response form.
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Products
Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096
- Brand
- Digene Corp
- UPC
- Lot 2447/ exp 2004-01 Lot 2476/ exp 2003-08-14 Lot 2569/ exp 2003-09-24 Lot 2570/ exp 2003-11 Lot 2577/ exp 2003-09-24 Lot 2646/ exp 2003-08
Units Affected
1858 kits/ 96 assays per kit