Recall Z-0145-2008 ยท MDK Dna-Probe, Reagents, Streptococcal
Gen-Probe Inc
Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
| Date | Dec 19, 2007 (initiated May 2, 2007) |
| Status | Terminated |
| Reason | Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches |
| Root cause | Other |
| Action | 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. |
| Quantity | 106 kits |
| Distribution | Nationwide: including states of AZ, CA, CO, FL, KY, MD, MO, NC, NJ, TX, and UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974572 | GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 Chugai Pharmaceuticals Co., Ltd., Sep 24, 1998 |