Z-0969-2010

BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number...

Name: Z-0969-2010 BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number...
Creator: Becton Dickinson & Co.
Published: 2009-09-18
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2009-09-18 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs on 2009-09-18. The reason FDA records is "Product was shipped beyond its expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0969-2010
Status: Terminated
Initiated: 2009-09-18
Posted: 2010-03-03
Terminated: 2010-03-24
Recalling firm: Becton Dickinson & Co
Product: BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs.
Product code: MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Reason for recall: Product was shipped beyond its expiration date.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recalling firm notified end users by letter flagged as "Urgent Product Recall" on 09/18/09. The notification advised that the referenced lot number had been correctly labeled with expiration date but had been shipped after the labeled date. End users were instructed to discontinue use discard product for replacement and return enclosed response form. If further assistance is needed regarding replacements, please contact SD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact SD Technical Services Department at 1-800-638-8663.
Quantity in commerce: 242 packs
Distribution: The product was sold for distribution to clinical laboratories nationwide and to the firm's international affiliate in Australia.
Product codes and lots: Lot 7016132, Exp date 01/17/09.

Product code MKZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)