FDA Device recall Z-2618-2014
The BD MAX MRSA Assay, catalogue #442953
- FDA Device
- Class II
- terminated
- Published 2014-09-17
On 2014-09-17 the FDA classified a Class II recall of The BD MAX MRSA Assay, catalogue #442953 by Becton Dickinson And, citing 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 tes….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2618-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-23 |
| Published | 2014-09-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Becton Dickinson And |
| Distribution | 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, WI |
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.
Reason
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.
Identifiers
| code_info | All Lots with the expiration date January 21, 2014 or later |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2618-2014%22
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