Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MagNA Pure 96

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall MagNA Pure 96see related information
Date Initiated by FirmJune 03, 2020
Create DateJuly 10, 2020
Recall Status1 Terminated 3 on October 04, 2023
Recall NumberZ-2551-2020
Recall Event ID 85838
Product Classification Clinical sample concentrator - Product Code JJH
ProductMagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purification rack position 1) before a purification run.
Code Information All units when used with Sample Transfer protocol version 3.0
FEI Number 2243471
Recalling Firm/
Manufacturer		 Roche Molecular Systems, Inc.
1080 US Highway 202 S
Branchburg NJ 08876-3733
For Additional Information ContactRoche Support Network Customer Support Center
800-526-1247
Manufacturer Reason
for Recall		When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96 instrument, which introduces a potential risk for cross-contamination leading to erroneous results.
FDA Determined
Cause 2		Software change control
ActionOn June 5, 2020, the firm distributed Urgent Medical Device Correction letters to consignee accounts. The UMDC instructs the customers to determine whether or not their laboratory is using the affected Sample Transfer protocol version 3.0 with their MagNA Pure 96 instrument. If the affected protocol is found on the instruments Control Unit, it needs to be immediately deleted by following the instructions provided in the UMDC. A newly updated Sample Transfer protocol version 4.0 is available. Roche Affiliate organizations will provide instructions for obtaining the new version of the protocol. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-1247 if you have questions about this recall.
Quantity in Commerce917
DistributionWorldwide distribution - US Nationwide distribution.
Total Product Life CycleTPLC 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.
-
-