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U.S. Department of Health and Human Services

Class 2 Device Recall Hycor HYTEC and Autostat II Rhemumatoid Factor IgM ELISA

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 Class 2 Device Recall Hycor HYTEC and Autostat II Rhemumatoid Factor IgM ELISAsee related information
Date Initiated by FirmMarch 19, 2018
Create DateAugust 06, 2019
Recall Status1 Open3, Classified
Recall NumberZ-2200-2019
Recall Event ID 83268
510(K)NumberK994338 
Product Classification System, test, rheumatoid factor - Product Code DHR
ProductHYTEC 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
FEI Number 1000125787
Recalling Firm/
Manufacturer		 Hycor Biomedical Inc
7272 Chapman Ave
Garden Grove CA 92841-2103
For Additional Information ContactKatie 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
ActionOn 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 Commerce288
DistributionWorldwide distribution to US state of TX , Netherlands, Belgium, Austria, Italy, and India
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 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) Database510(K)s with Product Code = DHR
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