Z-2618-2014 Class II Terminated
FDA device recall Z-2618-2014 was initiated by Becton Dickinson & Co. on Jul 23, 2014 and is designated Class II. 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… The recall status is terminated (terminated May 9, 2016). Affected quantity: 585,048 tests.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 17, 2014
- Initiation Date
- Jul 23, 2014
- Termination Date
- May 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 585,048 tests
Product Description
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.
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.
Distribution Pattern
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.
Code Information
All Lots with the expiration date January 21, 2014 or later
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2618-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026