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Terminated

Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121

FDA Recall Z-0145-2008 · Posted 2007-12-19

Recalling FirmGen-Probe Inc
Recall StatusTerminated
Product CodeMDK
Date Initiated2007-05-02
Date Terminated2010-05-03
Product Quantity106 kits

Reason for Recall

Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide: including states of AZ, CA, CO, FL, KY, MD, MO, NC, NJ, TX, and UT

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974572GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820Chugai Pharmaceuticals Co., Ltd. · 1998-09-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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