Z-2618-2014Class II

The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct...

Name: Z-2618-2014 The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct...
Creator: Becton Dickinson & Co.
Published: 2014-07-23
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2014-07-23 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Co. began a recall of The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus... on 2014-07-23. FDA classified it as Class II and gives the reason as "The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (>...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2618-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-23
Posted: 2014-09-10
Terminated: 2016-05-09
Recalling firm: Becton Dickinson & Co
Product: The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.
Product code: NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Reason for recall: The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab), produced negative results with the BD MAX MRSA Assay. One of the samples tested with each of the CAP surveys MRS5-A 2014 and MRS5-B 2014 yielded false positive results.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Becton Dickinson sent an Field Correction Notification initiated on July 23, 2014. US customers were contacted via letters sent by UPS. The letter identified the product the problem and the action needed to be taken by the customer. The acknowledgement form included with the follow up letter that is faxed back to BD will be reconciled with the customer list. BD will contact 10% of non-respondents to verify receipt of the customer letter. Any product returned to BD will be quarantined and discarded. Nonetheless, you may observe some false positive results for MSSA strains when using the above referenced product. Please contact the BD Technical Service Department at 1-800-638-8663 if you have observed an increase in MSSA false positive results or have failed the above referenced CAP surveys.
Quantity in commerce: 585,048 tests
Distribution: US Distribution including the states of : CA, FL, HI, IL, IN, MD, MI, MN, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI.
Product codes and lots: All Lots with the expiration date January 21, 2014 or later

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2618-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2618-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-10

Product code NQX

K120138Class IIBd Max Mrsa Assay, Bd Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc) / cleared 2012-07-05

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)