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U.S. Department of Health and Human Services

Class 2 Device Recall Elecsys BRAHMS PCT

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  Class 2 Device Recall Elecsys BRAHMS PCT see related information
Date Initiated by Firm December 22, 2017
Create Date April 04, 2018
Recall Status1 Terminated 3 on April 05, 2019
Recall Number Z-1311-2018
Recall Event ID 79462
510(K)Number K160729  
Product Classification Device to detect and measure procalcitonin (PCT) in human clinical specimens - Product Code PMT
Product Elecsys BRAHMS PCT

Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
Code Information Elecsys BRAHMS PCT: 07301715190 Lot number 204084
Recalling Firm/
Manufacturer		 Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Amanda Biedess
317-5214343
Manufacturer 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 47
Distribution US Distribution in states of: CA, FL and IN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PMT and Original Applicant = Roche Diagnostics
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