Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incor
FDA device recall Z-0145-2008 · posted 2007-12-19 · Terminated
Recall details
- Recalling firm
- Gen-Probe Inc
- Reason for recall
- Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MDK
- Quantity affected
- 106 kits
- Distribution
- Nationwide: including states of AZ, CA, CO, FL, KY, MD, MO, NC, NJ, TX, and UT
- Date initiated
- 2007-05-02
- Date posted
- 2007-12-19
- Date terminated
- 2010-05-03
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 (K974572) | Chugai Pharmaceuticals Co., Ltd. | 1998-09-24 |