Truseq recall & backorder?

[3gclone]

Has anyone experienced problems with Truseq recently particularly for RNA-Seq library construction? I also think these kits are on backorder?


October 9, 2014

Product Quality Notification

Dear Valued Customer,

We recently communicated (PQN0090 and PQN0090-2) a performance issue with RNA library preparation kits. In addition to the lots listed in those communications, we have identified an additional lot of affected PCR Master Mix. The following table has been updated with all affected component lots, and the Products Affected table at the end of this notice lists all products containing these components. This notice outlines our investigation and next steps.


Issue Summary and Status

Our initial investigation traced the issue to three lots of PCR Master Mix: 9975580, 9975588, and 9977504. These reagents did perform normally during quality control acceptance testing, but subsequent testing and customer feedback revealed inconsistent performance when used for RNA library preparation. These lots were manufactured using a single lot of DNA polymerase enzyme. Hence, this was initially believed to be a polymerase lot-specific issue. However, a fourth PMM lot (9994380), manufactured with a newer separate lot of enzyme, has begun to exhibit the same failure mode. This issue may be sporadic, with replicates from an individual tube giving different yields.

Although these reagents are also used in DNA library preparation kits, internal testing of DNA kits has not shown an effect on expected yield or sequencing performance. Additionally, the Nextera® Mate Pair Sample Prep Kit (FC-132-1001) was previously thought to be affected, however QC data shows that product performance meets specifications. Therefore, it has been removed from the table below.

We are working closely with our supplier to resolve this issue and ensuring appropriate steps are taken to prevent recurrence. Until there is resolution, the affected products will not be manufactured or shipped. We expect that the investigation and implementation of corrective actions will result in product availability by the beginning of November.

Next Steps
Email Technical Support if you have unused boxes corresponding to the lots listed above or, if you used kits from these lots and experienced lower than expected yield. Emails should include box part numbers and serial numbers if available. Illumina Technical Support will create an order for product replacement.

Once manufacturing of the products resumes, the product replacement orders will be fulfilled and shipped. If a product availability update is required, please email either Technical Support or Customer Service.

Please forward this information to anyone who might be impacted by this issue. We greatly appreciate your continued business and regret any inconvenience this may have caused.
Sincerely,

Products Affected
Products Catalog Number
TruSeq RNA Access - Coding Transcriptome, Set A RS-301-2001
TruSeq RNA Access - Coding Transcriptome, Set B RS-301-2002
TruSeq Demo Enrichment FC-121-1007
TruSeq RNA Sample Prep Kit-v2, 48, Set A RS-122-2001
TruSeq RNA Sample Prep Kit-v2, 48, Set B RS-122-2002
TruSeq ChIP Sample Prep Kit 48 Samples - Set B IP-202-1024
TruSeq ChIP Sample Prep Kit 48 Samples - Set A IP-202-1012
TruSeq Stranded mRNA LT - Set A RS-122-2101
TruSeq Stranded mRNA LT - Set B RS-122-2102
TruSeq Stranded Total RNA LT Ribo-Zero HMR Set B RS-122-2202
TruSeq Stranded Total RNA LT Ribo-Zero HMR Set A RS-122-2201
TruSeq Stranded Total RNA LT Ribo-Zero Gold Set A RS-122-2301
TruSeq Stranded Total RNA LT Ribo-Zero Gold Set B RS-122-2302
TruSeq Stranded Total RNA LT Ribo-Zero Plant Set A RS-122-2401
TruSeq Stranded Total RNA LT Ribo-Zero Plant Set B RS-122-2402
TruSeq Stranded Total RNA LT Ribo-Zero Globin Set A RS-122-2501
TruSeq Stranded Total RNA LT Ribo-Zero Globin Set B RS-122-2502
TruSeq Stranded mRNA HT RS-122-2103
TruSeq Stranded Total RNA HT Ribo-Zero HMR RS-122-2203
TruSeq Stranded Total RNA HT Ribo-Zero Gold RS-122-2303
TruSeq Stranded Total RNA HT Ribo-Zero Plant RS-122-2403
TruSeq Stranded Total RNA HT Ribo-Zero Globin RS-122-2503
TruSight Enrichment Kit (24 Indices - 48 Samples) FC-123-1203

[flxlex]

Follow up information from Illumina:

If libraries that were generated using these reagents were sequenced, please quarantine these libraries to prevent further use. We do not recommend using data generated from those sequencing runs. Illumina will replace the sequencing reagents used to sequence these libraries. If possible, provide a list of box part numbers and serial numbers of library preparation kits that were used. Please provide a list of sequencing runs for these libraries, including the platform and type of run (single-read versus paired-end, and number of cycles) and the serial number of clustering and sequencing reagent kits, if available.

We lost 300 samples and 2 weeks of HiSeq run time...

[VanessaS]

Is anyone else still experiencing issues with these kits?