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 Hycor HYTEC and Autostat II Rhemumatoid Factor IgM ELISA

  • 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 Hycor HYTEC and Autostat II Rhemumatoid Factor IgM ELISA see related information
Date Initiated by Firm March 19, 2018
Create Date August 06, 2019
Recall Status1 Open3, Classified
Recall Number Z-2200-2019
Recall Event ID 83268
510(K)Number K994338  
Product Classification System, test, rheumatoid factor - Product Code DHR
Product HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only.

HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.
Code Information All lots of RF assay
Recalling Firm/
Manufacturer		 Hycor Biomedical Inc
7272 Chapman Ave
Garden Grove CA 92841-2103
For Additional Information Contact Katie Weinkauf
714-933-3020
Manufacturer Reason
for Recall		 Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid.
FDA Determined
Cause 2		 Labeling design
Action On March 19, 2018, Hycor Biomedical sent a "Urgent Field Safety Notice" via Federal Express to consignees. The urgent field safety notices recommending the following steps to detect and minimize possible sample carryover: 1. Repeat testing of all patient samples for the HYTEC AUTOSTAT II RF assays when the negative control reports out of range. 2. Do not perform HYTEC AUTOSTAT II RF assays in batch mode. HYTEC AUTOSTAT II RF should be tested independently of all other autoimmune assays. 3. Performing testing in duplicate may assist in detecting potential carryover of high levels of IgG from one sample into another reaction well. If the duplicate results do not match, sample carryover may be the root cause. 4. The needle tip of the single tip arm should be cleaned weekly, according to the recommended maintenance schedule. The needle tip should be inspected for damage; a damaged needle tip should be replaced by trained service personnel. 5. It is mandatory that all consignees complete and return the enclosed response within 10 days of receipt, in order for us to verify your understanding of this Field Safety Notice. If you have any questions, please contact Hycor Biomedical at 714-933-3000
Quantity in Commerce 288
Distribution Worldwide distribution to US state of TX , Netherlands, Belgium, Austria, Italy, and India
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DHR and Original Applicant = COGENT DIAGNOTICS LTD.
-
-