Z-0854-2022Class II

Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

Name: Z-0854-2022 Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Creator: Illumina, Inc.
Published: 2022-02-22
License: https://open.fda.gov/license/

Illumina, Inc. / initiated 2022-02-22 / Completed / root cause: design

FDA source

Illumina, Inc. began a recall of Illumina NextSeq 550Dx, REF: 20005715, CE, IVD on 2022-02-22. FDA classified it as Class II and gives the reason as "There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-0854-2022
Classification: Class II
Status: Completed
Initiated: 2022-02-22
Posted: 2022-03-31
Recalling firm: Illumina, Inc.
Product: Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Product code: PFF High Throughput Dna Sequence Analyzer
Reason for recall: There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.
Root cause tag: design
FDA root cause: Device Design
Action: On February 22, 2022 Illumina issued a "Urgent Field Safety" recall notice to all affected consignees via E-Mail. The firm issued an amended "Urgent Medical Device" recall notice on March 11, 2022 via email to provide consignees with additional information. In addition to notifying consignees about the recall, the firm asked consignees to take the following actions: 1. Complete the attached FSN2022-125 verification form to confirm receipt of the notification and return the form to Technical Support at [email protected] within 5 business days. 2. If you have not already sent Illumina the Verification Form attached to FSN2022-1215, please complete the attached copy of the form and return it to Technical Support at [email protected] within 5 business days. No additional action is required at this time 3. Please note, if an operator experiences an adverse event with the use of this product, user may report this to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 674 instruments
Distribution: US: PA, WA, CA, MI, FL, MD, AR, UT NC, Fl, IL, NE, NJ, TN, NY, IN, CO, GA, OK, TX, CT, SD, NM, VA, AL, LA, SC, WV, OR, IA, AZ, MN OUS: Australia Austria Belgium Chile China Denmark Finland France Germany Hungary Ireland Italy Japan Latvia Netherlands Norway Poland Portugal Romania Russian Federation Saudi Arabia Singapore Slovakia South Africa South Korea Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom Vietnam
Product codes and lots: Lot #s NDX550110 - NDX550843 ; UDI: (01)00816270020125

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0854-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0854-2022	Class II	Completed	Voluntary: Firm initiated	2022-04-06	2022-03-31

Product code PFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)