"Diagnostic test strips and cassettes for urinalysis, pregnancy testing, menopause testing and opiates testing, manufactured by:
IND Diagnostics Inc, Canada
Alere International Ltd
Barrier Healthcare Ltd
E-Pharm Ltd
The table below lists test strips that have been supplied in the UK between January 2011 and March 2013
Manufacturer
Device Type
Device Name
IND Diagnostics
Urinalysis Reagent Test Strips
Urinalysis Reagent Test Strips
IND Diagnostics
HCG Pregnancy Test
Indicator One-Step Urine Pregnancy Test (Cassette Format)
Indicator One-Step Urine Pregnancy Test (Ministrip Format)
Indicator One-Step Home Pregnancy Test (Midstream Format)
Indicator One-Step Home Pregnancy Test (Mini-Midstream Format)
IND Diagnostics
FSH Menopause tests
One Step FSH Menopause Test (Strip Format)
One Step FSH Menopause Test (Cassette Format)
One Step FSH Menopause Test (Midstream Format)
IND Diagnostics
Opiates Test
IND One Step Opiates Test
Alere International Ltd.
HCG Pregnancy test
Axis Shield Pregnancy test dipstick and cassette
Barrier Healthcare Ltd
Urinalysis Reagent Test Strips
DIA-CHECK Urinalysis Reagent Strips
E-Pharm
HCG Pregnancy Test
PREGTEST
(Strip format)
PREGTEST
(Cassette format)
PREGTEST
(Midstream format)"
Biokit Best 2000 laboratory analyser used in combination with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay.
The Biokit Best 2000 is also on the market as the Dynex Technologies DSX laboratory analyser.
PROBLEM:
The MHRA has received a report from a laboratory of an unrepeatable positive HIV test result. The positive result was not confirmed when further routine testing was carried out. The result was generated using a Biokit Best 2000 laboratory analyser in combination with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay.
The cause of the false result has not been determined. However, Biokit has stated that they have not validated this test for use on the analyser and they cannot guarantee the accuracy, reproducibility or performance of this combination. BioMerieux has stated that although the analyser meets the specifications set out in their instructions for use, this combination of assay and laboratory analyser has not been validated by them.
ACTION: