Gen-Probe Inc Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
Brand
Gen-Probe Inc
Lot Codes / Batch Numbers
Catalog Number 2820B, Lot Number 531379
Products Sold
Catalog Number 2820B; Lot Number 531379
Gen-Probe Inc is recalling Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 5313 due to Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches
Recommended Action
Per FDA guidance
Gen-Probe notified customers by phone on May 2nd and 3rd, 2007; a recall notice letter was faxed to each customer on May 3rd, 2007 and mailed on May 4th, 2007 via certified mail. The letter describes the packaging error and the remote health hazard risk, and provides instructions for users to return all kits of this lot number.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026