Reported Apr 1, 2015 · Terminated
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Roche Molecular Systems, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Molecular Systems, Inc. · 1080 Us Highway 202 S · Branchburg, NJ · 08876-3733
Is this the product you have?
- cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
- Lot codes and dates
- T08661
- Amount recalled
- 190 kits
Why it was recalled
False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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