FDA Device recall Z-1528-2017
ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024
- FDA Device
- Class II
- terminated
- Published 2017-03-29
On 2017-03-29 the FDA classified a Class II recall of ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024 by Biomerieux, citing product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1528-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-15 |
| Published | 2017-03-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions
Reason
Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.
Identifiers
| code_info | Reference no. 529140, Lot #1001390510, 1001441860, 1001609400, 1001733320, 1001761030, 1001920530, 1001966610, 10020093…Reference no. 529140, Lot #1001390510, 1001441860, 1001609400, 1001733320, 1001761030, 1001920530, 1001966610, 1002009360, 1002084930, 1002106570, 1002158050, 1002168110, 1002395840, 1002452170, 1002500020, 1002604960, 1002992250, 1003030810, 1003127520, 1003274260, 1003322150, 1003412730, 1003535930, 1003678890, 1003800400, 1004100220, 1004177630, 1004365540, 1004410620, 1004557900, 1004703240, 1004783050, 1004838760, 1005034320, 1005097790, 1005151830; Reference no. 529148, Lot #1001368050, 1001442030, 1001566960, 1001578760, 1001708630, 1001833500, 1001894590, 1001920200, 1001955170, 1002084950, 1002172820, 1002226550, 1002410940, 1002451250, 1002501640, 1002604970, 1002964340, 1002992260, 1003121770, 1003274280, 1003491070, 1003526920, 1003626710, 1003743380, 1003946090, 1004037330, 1004273540, 1004323330, 1004557890, 1004593710, 1004696420, 1004790240, 1005031600, 1005098130, 1005151890 & 1005151920; Reference no. 529100, Lot #1001324170, 1001378120, 1001403920, 1001433710, 1001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1528-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.