RecallRadar

FDA Device recall Z-2461-2017

VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards per carton

On 2017-06-21 the FDA classified a Class II recall of VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards per carton by Biomerieux, citing the integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2461-2017
ClassificationClass II
Statusterminated
Initiated2017-04-20
Published2017-06-21
Last updated2026-09-13 11:54 UTC
CompanyBiomerieux
DistributionUS

Product

VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards per carton.

Reason

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Identifiers

code_info
2870115203 21/Mar/18 2870125203 31/Mar/18 2870129203 04/Apr/18 2870129223 04/Apr/18 2870143203 18/Apr/18 287015020…2870115203 21/Mar/18 2870125203 31/Mar/18 2870129203 04/Apr/18 2870129223 04/Apr/18 2870143203 18/Apr/18 2870150203 25/Apr/18 2870157203 02/May/18 2870209403 23/Jun/18 2870221203 05/JUL/18 2870235203 19/Jul/18 2870241203 25/Jul/18 2870241223 25/Jul/18 2870248403 01/Aug/18 2870276203 29/Aug/18 2870283103 05/Sep/18 2870283203 05/Sep/18

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-2461-2017%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.