Garden Grove, CA, United States
Hycor Biomedical Inc recalls
3 recalls recorded since 2018, most recently on 25 July 2018. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 July 2018
- Reason
- Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
- Distribution
- Stop Solution bottles were distributed to AL, CA, FL, IL, KS, LA, MS, NJ, NY, SC, TX, WA, and to the U.S. Virgin Islands. Foreign distribution of the bottles was made to Germany. There was no government/military distribution. Assay kits containing the Stop Solution bottles were distributed to
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0224-2020
- HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; a
Ongoing Class II Medical devices
- Recall started
- 19 March 2018
- Reason
- 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.
- Distribution
- Worldwide distribution to US state of TX , Netherlands, Belgium, Austria, Italy, and India
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2200-2019
- 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 Ki
Completed Class II Medical devices
- Recall started
- 21 February 2018
- Reason
- Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor.
- Distribution
- U.S.: TX. Foreign (OUS): Netherlands, Belgium, Austria, Italy, India
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2134-2019
- AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked im
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.