Paper, Obstetric Ph
Clinical Chemistry · 21 CFR 862.1550
Recent MDR events
5 adverse event reports on file
- HYDRIONMar 4, 2022MalfunctionMicro Essential Laboratory, Inc.13666400
- MICRO ESSENTIAL LABORATORY PH PAPERMar 12, 2010MalfunctionMicro Essential LaboratoryMW5015133
- APOTHECONSep 24, 1996MalfunctionBristol-myers SquibbMW4001508
- APOTHECONSep 11, 1996MalfunctionBristol-myers SquibbMW4001509
- APOTHECON NITRAZINE PAPERFeb 3, 1994Bristol Myers Squibb Co,MW4000200
Event type breakdown
Recalls
2 recall events for this product code
- Changchun Wancheng Bio-Electron Co., Ltd.Open, ClassifiedFeb 4, 2026
Vivoo Vaginal pH Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Z-1266-2026 · View FDA record ↗ - Instrumentation Laboratory Co.TerminatedOct 15, 2003
Lactate Disposable Membrane Caps
Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L.
Z-0027-04 · View FDA record ↗
Registered firms
34 firms currently registered for this product code
Changchun Lyz Technology Co.,ltd
Changchun City Jilin, CN
Genabio Diagnostics Inc
Bedford, MA, US
Hangzhou Alltest Biotech Co.,ltd
Hangzhou Zhejiang, CN
Shoney Scientific, Inc.
WAUKESHA, WI, US
Assure Tech. (hangzhou) Co., Ltd.
Hangzhou Zhejiang, CN
Hong Kong Medsourcing Limited
KOWLOON, HK
Meditec Devices
VASAI(E), THANE, MAHARASHTRA, IN
2san Llc
New York, NY, US
Assure Tech. (hangzhou) Co., Ltd.
Hangzhou Zhejiang, CN
Fridababy Llc
Miami, FL, US
Winx Health Inc
Reading, PA, US
Changchun Wancheng Bio-electron Co., Ltd.
Changchun Jilin, CN
Henso Medical (hangzhou) Co.,ltd.
Hangzhou Zhejiang, CN
Jilin Hongyi Bio-tech Co., Ltd.
Changchun Jilin, CN
Pelvana Health, Llc
Fort Worth, TX, US
Micro Essential Laboratory, Inc.
Brooklyn, NY, US
I-health, Inc.
Enfield, CT, US
Safecare Biotech(hangzhou)co.,ltd
Huzhou Zhejiang, CN
Home Health Us Incorporated
Sarasota, FL, US
Gynex Corporation
North Richland Hills, TX, US
Xiamen Mk Health Care Product Co., Ltd.
XIAMEN Fujian, CN
Changchun Merydi Bio-tech Co., Ltd.
changchun Jilin, CN
Jilin Test Bio-electron Co.,ltd
Changchun Jilin, CN
Easy Healthcare Corporation
Darien, IL, US
Vivosens Inc
San Francisco, CA, US