Becton Dickinson & Co.: 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.

Recall number

Z-2658-2011

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.

Status

Terminated

Initiated

2010-09-29

Posted

2011-06-24

Terminated

2011-06-24

Reason

In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results.

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

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.

Lot, serial or model codes

Lot 0158908 exp May 31, 2011 and Lot 0158969 exp May 31, 2011

510(k) numbers

["K984631"]

PMA numbers

not on file

Product code

MKZ

Firm FEI

1119779

Firm city

Sparks

Firm state

MD

Firm country

not on file

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

Copy