Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since l

FDA device recall Z-0947-2015 · posted 2015-01-12 · Terminated

Recall details

Recalling firm

Phadia US Inc

Reason for recall

During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run.

Action taken

ThermoFisher sent an Urgent Medical Device Product Correction letter to all affected customers. The firm will inform customers of the specific sequence of errors and operator actions that can trigger the event via letter and phone, and will request that they do not respond to the Barcode Read Error and let the sample with the error eject normally from the instrument and be rerun after the barcode read error has been resolved. The firm will issue a mandatory Phadia 1000 Instrument Software (ISW) update that will correct the issue and make efforts to install it within 45 days from date of availability. Customers were asked to return the written response form via fax to: 1-888-243-5214 Attention: Customer Support, Phadia 1000 ISW Product Correction Response; EMAIL: Compliance-us.idd@thermofisher.com Email Subject Line: Phadia 1000 ISW Product Correction Response. Customers with questions were instructed to contact Phadia US Technical Support at 800-346-4364, option 2. For questions regarding this recall call269-492-1957.

Root cause

Software design

Status

Terminated

Product code

DHB

Quantity affected

146

Distribution

Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI IL, IN, KS, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.

Date initiated

2014-11-20

Date posted

2015-01-12

Date terminated

2015-06-30

Location

Portage, MI

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