Z-0312-2019Class II

BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) -

Name: Z-0312-2019 BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) -
Creator: Becton Dickinson & Co.
Published: 2018-09-24
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-09-24 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in... on 2018-09-24. FDA classified it as Class II and gives the reason as "A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive". 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-0312-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-24
Posted: 2018-10-31
Terminated: 2020-04-10
Recalling firm: Becton Dickinson & Co
Product: BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.
Product code: PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Reason for recall: A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urgent Medical Device Product Recall notification letters dated 9/24/18 were sent to customers.
Quantity in commerce: 23
Distribution: Worldwide distribution - US nationwide in the states of AL, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico. Countries of Spain, Germany, France, Austria, Denmark, Switzerland, Sweden, Italy, Kuwait, Oman, Saudi Arabia, and Turkey.
Product codes and lots: Serial Numbers: 079577 to 079896, 78154, 78503, 78363, 78321, 78584, 78840, 78975, 78711, 77048, 79783, 78857, 79162, 78387, 78182, 78832, 78905, 77062, 78856, 78352, 78903, 78667, 78665, 78928, 78986, 77108, 77543, 78615, 78481, 77373, 77707, 78927

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0312-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0312-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0313-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31

Product code PQA

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)