FDA Medical Device Recalls (openFDA)
Gen-Probe Inc: Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
- Recall number
- Z-0145-2008
- Recalling firm
- Gen-Probe Inc
- Product
- Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
- Status
- Terminated
- Initiated
- 2007-05-02
- Posted
- 2007-12-19
- Terminated
- 2010-05-03
- 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
- Lot, serial or model codes
- Catalog Number 2820B; Lot Number 531379
- 510(k) numbers
- ["K974572"]
- PMA numbers
- not on file
- Product code
- MDK
- Firm FEI
- 2024800
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28