Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
FDA Recall Z-1311-2018 · Posted None
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Recalling FirmRoche Diagnostics Corporation
Recall StatusTerminated
Product CodePMT
Date Initiated2017-12-22
Date Terminated2019-04-05
Product Quantity47
Reason for Recall
Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.
Firm Action
The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated December 22, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
" Immediately discontinue use of Elecsys BRAHMS PCT (catalog number 07301715190) reagent lot
number 204084 on the cobas e 801 module.
" Discard affected product according to local guidelines.
" Complete the attached fax form and fax it to 1-800-722-7222.
" File this Urgent Medical Device Removal (UMDR) for future reference.
Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDR.
Root Cause
Software design
Distribution Pattern
US Distribution in states of: CA, FL and IN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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