Recall Z-0145-2008
Gen-Probe Inc · initiated May 2, 2007
Product
Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
Codes / lots: Catalog Number 2820B; Lot Number 531379
Reason for recall
Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0145-2008
- Initiated
- May 2, 2007
- Posted by FDA
- December 19, 2007
- Terminated
- May 3, 2010
- Product code
- MDK – Dna-Probe, Reagents, Streptococcal
- Quantity
- 106 kits
- Distribution
- Nationwide: including states of AZ, CA, CO, FL, KY, MD, MO, NC, NJ, TX, and UT
- Recalling firm
- Gen-Probe Inc, San Diego, CA