Illumina Inc: Medical Device Recall in 2014 - (Recall #: Z-0849-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.

Product Classification:

Class II

Date Initiated: November 13, 2014

Date Posted: December 31, 2014

Recall Number: Z-0849-2015

Event ID: 69766

Reason for Recall:

It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific genomic locations with respect to the primer.

Status: Terminated

Product Quantity: 13 units

Code Information:

Serial No. M70130, M70189, M70108, M70165, M70166, M70175, M70172, M70103.

Distribution Pattern:

US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.

Voluntary or Mandated:

Voluntary: Firm initiated