Medical Device Recall: Z-0028-2018

FDA Recalls dataset · Firm: Cepheid · Status: Terminated

Recall Action Class: N/A Date Initiated: 2017-09-15 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0028-2018.

Recall Res Number
Z-0028-2018
Recalling Firm / Manufacturer
Cepheid
FEI Number
3004530258
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2017-09-15
Date Posted
N/A
Date Terminated
2023-07-28
Product Code
N/A
Event Number
78177
Product Quantity
977 kits (9770 units)
Product Description Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and symptoms of meningitis.
Reason for Recall Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Action Details Recall notification letters were sent out to affected consignees on 9/15/17.
Distribution Pattern USA, Austria, Australia, Belgium, Brazil, Canada, Chile, Colombia, Germany, Spain, France, UK, Ireland, Israel, Italy, South Korea, Lebanon, Netherlands, Philippines, Saudi Arabia, Sweden, Uruguay
Code Information / Serial Numbers batch 1000045409 (lot 06802)

Related Establishments / Registrations

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