VITEK 2 Gram Negative Susceptibility card (AST-N323), IVD, REF 418602, 20 cards per carton.

FDA device recall Z-2489-2017 · posted 2017-05-22 · Terminated

Recall details

Recalling firm

Biomerieux Inc

Reason for recall

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

Action taken

The firm posted their recall notification on their customer website on 4/20/2017. The firm sent the recall notification letter to their customers via FedEx on 4/21/2017 for delivery 4/24/2017. A follow-up recall notice will be issued on 5/08/2017 which identified 3 additional lots impacted by the recall.

Root cause

Packaging

Status

Terminated

Product code

N/A

Quantity affected

3,172 cartons

Distribution

Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium,

Date initiated

2017-04-20

Date posted

2017-05-22

Date terminated

2020-07-22

Location

Hazelwood, MO