Z-2658-2011

BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7...

Name: Z-2658-2011 BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7...
Creator: Becton Dickinson & Co.
Published: 2010-09-29
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2010-09-29 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152*** The BD ProbeTec" ET... on 2010-09-29. The reason FDA records is "In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results". 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-2658-2011
Status: Terminated
Initiated: 2010-09-29
Posted: 2011-06-24
Terminated: 2011-06-24
Recalling firm: Becton Dickinson & Co
Product: BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152*** The BD ProbeTec" ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when tested with the BD ProbeTec ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper" instrument.
Product code: MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Reason for recall: In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated September 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to discontinue use of the product and discard any remaining product. BD will replace any discarded products. Additionally, customers were requested to complete and return an attached form whether or not they have any inventory remaining, to confirm receipt of the notification. The letter instructed the customers to fax the completed form to: Attention: Regulatory Compliance at 410-316-4258. For assistance regarding replacements, contact BD Customer Service Department at 1-800-675-0908. All other inquiries should contact BD Technical Services Department at 1-800-638-8663.
Quantity in commerce: 130 kits
Distribution: Worldwide Distribution--USA (nationwide) including the states of AL, CA, CO, CT, FL, GA, KY, LA, ME, MN, MO, MS, MT, NE, OH, PA, RI, TX, and WA and the countries of Australia, Canada, Europe, and Japan.
Product codes and lots: Lot 0158908 exp May 31, 2011 and Lot 0158969 exp May 31, 2011

Product code MKZ

K984631Class IIBdprobetec Et Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified DNA AssayBecton Dickinson Microbiology Systems / cleared 1999-11-04

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)