Z-0145-2008

Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379...

Name: Z-0145-2008 Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379...
Creator: Gen-Probe Inc
Published: 2007-05-02
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2007-05-02 / Terminated / root cause: packaging

FDA source

Gen-Probe Inc began a recall of Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121 on 2007-05-02. The reason FDA records is "Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0145-2008
Status: Terminated
Initiated: 2007-05-02
Posted: 2007-12-19
Terminated: 2010-05-03
Recalling firm: Hologic, Inc.
Product: Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
Product code: MDK Dna-Probe, Reagents, Streptococcal
Reason for recall: Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches
Root cause tag: packaging
FDA 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 in commerce: 106 kits
Distribution: Nationwide: including states of AZ, CA, CO, FL, KY, MD, MO, NC, NJ, TX, and UT
Product codes and lots: Catalog Number 2820B; Lot Number 531379

Product code MDK

K974572Class IGen-Probe Accuprobe Group B Streptococcus Culture Identification Test 2820Chugai Pharmaceuticals Co., Ltd. / cleared 1998-09-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)