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Diagnostic tests manufactured by IND Diagnostic or other private label manufacturers
- Starting date:
- February 8, 2013
- Posting date:
- February 8, 2013
- Type of communication:
- Information Update
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Issue:
- Unauthorized products
- Audience:
- General Public
- Identification number:
- RA-23151
- What you should do
- Report health or safety concerns
- Media enquiries
- Public enquiries
- What Health Canada is doing
Health Canada today suspended all medical device licences issued to and associated with IND Diagnostic of Delta, B.C., under its powers in the Food and Drugs Act, because of concerns about the company's management systems and distribution practices. The suspension means the devices can no longer be legally sold in Canada by any person. Health Canada's decision to suspend these licences is not based on an identified issue with the safety and effectiveness of any particular device.
The devices whose licences were suspended were sold directly by IND Diagnostic or by one of 13 private label manufacturers. The private label manufacturers are companies that purchased IND Diagnostic products and sold them under other names.
The devices include test kits used in pregnancy and ovulation, screening for blood in stool, urinary tract infections, infectious disease and illicit drugs. Some of the tests were sold in retail outlets, including discount/dollar stores for home use, while others were only sold for use by health professionals or laboratories.
In addition to the concerns about IND Diagnostic's management system for licenced devices, Health Canada found the company was importing unlicensed medical devices mainly for export to other countries. Health Canada is not aware of these unlicensed devices being distributed to the Canadian public or the health care system. When Health Canada discovered this situation, it notified its international health partners and the Canada Border Services Agency to help ensure the devices were no longer being imported. IND Diagnostic has voluntarily recalled these unlicensed devices.
The following chart lists the diagnostic tests (with their medical device license numbers) manufactured by IND Diagnostic or other private label manufacturers that had their licences suspended by Health Canada on Feb. 8, 2013. This suspension is immediate and means that the medical devices (the diagnostic tests listed below) included in these licences can no longer be legally sold in Canada by any person.
| Diagnostic Test | Product Name and License Number | Manufacturers | Area of Use |
|---|---|---|---|
| Fertility-related tests | |||
| FSH (Follicle-Stimulating Hormone) Menopause tests | One Step FSH Menopause Test - Strip (64332) | IND | Home Use and Professional Use |
| One Step FSH Menopause Test - Cassette (64332) | |||
| One Step FSH Menopause Test - Midstream (64332) | |||
| Pregnancy tests | Indicator One-Step Urine Pregnancy Test (Cassette Format)(8709) | IND | Home Use and Professional Use |
| Indicator One-Step Urine Pregnancy Test (Ministrip Format)(8711) | |||
| Indicator One Step-Urine & Serum Combo Pregnancy Test (8712) | |||
| Indicator One-Step Urine & Serum Combo Pregnancy Test (Ministrip Format) (8714) | |||
| Indicator One-Step Home Pregnancy Test (Midstream Format) (8739) | |||
| Indicator One-Step Home Pregnancy Test (Mini-Midstream Format) (8739) | |||
| Pro-Care One Step Pregnancy Test (70432) | A&D Fiesta Inc. | Home Use and Professional Use | |
| New Choice Pregnancy Test (68694) | Sales Enterprises | Home Use and Professional Use | |
| Baby Check-1 One Step Pregnancy Test (68977) | |||
| U-Check Pregnancy Test (73411) | |||
| New Choice Plus One Step Pregnancy Test (68976) | SCI International | Home Use and Professional Use | |
| IMCO Pregnancy Test Ministrip (87644) | Independent Medical Co-op Inc. | Home Use and Professional Use | |
| IMCO Pregnancy Test Cassette (87645) | |||
| IMCO HCG Combo Pregnancy Test(87647) | |||
| Accurate Diagnostics Pregnancy Test Cassette (85355) | Lake Erie Wholesale Medical Supply | Home Use and Professional Use | |
| Accurate Diagnostics Pregnancy Test Ministrip (87648) | |||
| Impulse! & Co. One Step Pregnancy Test (86235) | Deejay Jewellery Inc. | Home Use and Professional Use | |
| Ovulation tests | Indicator One-Step Urine Ovulation Test (Cassette Format) (8717) | IND | Home Use and Professional Use |
| Indicator One-Step Urine Ovulation Test (Ministrip Format) (8718) | |||
| Indicator One-Step Home Ovulation Test (Midstream Format) (8720) | |||
| Pro-Care Ovulation Predictor (81342) | A&D Fiesta Inc. | Home Use and Professional Use | |
| Quick Result (88011) | Best Beauty Lines | Home Use and Professional Use | |
| Test De Grossesse Ultra Simple (74365) | Bio Laval Inc. | Home Use and Professional Use | |
| Test De Grossesse Ultra (80657) | |||
| Test De Grossesse Biomedic (78810) | Familiprix Inc. | Home Use and Professional Use | |
| New Choice Ovulation Predictor (69117) | Sales Enterprises | Home Use and Professional Use | |
| Screening tests | |||
| Fecal occult blood tests | One-Step Fecal Occult Blood Test-Strip (67051) | IND | Laboratory Use |
| One-Step Fecal Occult Blood Test-Cassette (67051) | |||
| Rapid Response One-Step Fecal Occult Blood Test-Cassette (75345) | BTNX Inc. | Laboratory Use | |
| Rapid Response One-Step Fecal Occult Blood Test-Strip (75345) | |||
| FOB Advanced + (Cassette)(85227) | Gecko Pharma Vertrieb GmbH | Laboratory Use | |
| Rapidtech Plus IFOBT Test (90220) | Genix Technology Inc. | Laboratory Use | |
| Rapidtech IFOBT Test (90220) | |||
| IFOB Test (90005) | Innovatek Medical Inc. | Laboratory Use | |
| IFOB Test Strip (90005) | |||
| Alpha Fetoprotein tests | Indicator One-Step Serum AFP (Alpha Fetoprotein) Test (Cassette Format) (10864) | IND | Laboratory Use |
| Indicator One-Step Serum AFP (Alpha Fetoprotein) Test (Ministrip Format) (10865) | |||
| Rapid Response One Step Serum AFP (Alpha Fetoprotein) Test (Ministrip Fromat) (75700) | BTNX Inc. | Laboratory Use | |
| Rapid Response One Step Serum AFP (Alpha Fetoprotein) Test (Cassette Format) (75701) | |||
| Urinalysis reagent strips | |||
| Urinalysis reagent strips | Urinalysis Reagent Test Strips (10 Parameters) (61840) | IND | Laboratory Use |
| Urinalysis Reagent Test Strips (11 Parameters) (61840) | |||
| IND Microalbumin and Creatinine Urine Reagent Strips (87871) | IND | Laboratory Use | |
| IND Urinary Tract Infection (UTI) Test Strips (86201) | |||
| Rapidtech UG Reagent Strips for Urinalysis (90221) | Genix Technology Inc. | Laboratory Use | |
| IMCO Urine Screen Urinalysis Reagent Strips(87646) | Independent Medical Co-op Inc. | Laboratory Use | |
| Accurate Diagnostics Urinalysis Reagent Strips (87649) | Lake Erie Wholesale Medical Supply | Laboratory Use | |
| IND urine analyzer | IND Urine Analyzer (67975) | IND | Laboratory Use |
| Infectious Diseases | |||
| Infectious Diseases | Indicator One-Step Gonorrhea Swab Test (Cassette Format) (10866) | IND | Home, Laboratory and Professional Use |
| Indicator One-Step Gonorrhea Swab Test (Ministrip Format) (10867) | |||
| IND One Step Malaria Antigen P.F/PAN Test (87042) | |||
| IND One Step Malaria Anti-P.F/P.V Test (88211) | |||
| One Step Dengue IGG/IGM Test (89823) | |||
| Rapid Response One-Step Gonorrhea Swab Test (Ministrip Format) (75702) | BTNX Inc. | Laboratory Use | |
| Rapid Response One-Step Gonorrhea Swab Test (Cassette Format) (75703) | |||
| Pharmaceutical and Recreational Drugs of Abuse tests | |||
| Methadone test | One Step Methadone Test - Cassette (72204) | IND | Laboratory Use |
| One Step Methadone Test - Strip (72204) | |||
| MDMA (Ecstasy) test | One Step MDMA Test - Cassette (72205) | IND | Laboratory Use |
| One Step MDMA Test - Strip (72205) | |||
| Phencyclidine (or PCP) test | IND One Step Phencyclidine Test - Strip Format (81194) | IND | Laboratory Use |
| IND One Step Phencyclidine Test - Cassette Format (81194) | |||
| Benzodiazepine (abbreviated BZD) test | IND One-Step Benzodiazepine Test - Strip Format (81196) | IND | Laboratory Use |
| IND One-Step Benzodiazepine Test - Cassette Format (81196) | |||
| Opiates test | IND One Step Opiates Test (81199) | IN | Laboratory Use |
| Cocaine test | One Step Cocaine Test Cassette Format (38772) | IND | Laboratory Use |
| One Step Cocaine Test Ministrip Format (38772) | |||
| Marijuana test | One Step Marijuana Test (Urine) (60163) | IND | Laboratory Use |
| Methamphetamine (Meth) test | One Step Methamphetamine Test - Cassette Format Met-C (61003) | IND | Laboratory Use |
| One Step Methamphetamine Test - Strip Format Met-S (61003) | |||
| Amphetamine test | One Step Amphetamine Test - Cassette Format Amp-C (61004) | IND | Laboratory Use |
| One Step Amphetamine Test - Strip Format Amp-S (61004) | |||
| Alcohol Saliva test | One Step Alcohol Saliva Test (62883) | IND | Laboratory Use |
| Morphine Tests | One Step Morphine Test Cassette Format (38773) | IND | Laboratory Use |
| One Step Morphine Test Ministrip Format (38773) | |||
| Drug Abuse Test | One Step Drugs of Abuse Multi-Test (63034) | IND | Laboratory Use |
| IND One Step Multi-Panel Drugs of Abuse Test (81197) | |||
| Antidepressants test | IND One Step Tricyclic Antidepressants Test (81195) | IND | Laboratory Use |
| Barbiturates Test | IND One Step Barbiturates Test (81198) | IND | Laboratory Use |
What you should do
Should patients or health professionals wish to confirm previous test results, there are authorized alternatives available in Canada for all the test kits whose licences have been suspended.
Report health or safety concerns
Complaints about medical devices can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:
Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Media enquiries
Health Canada
(613) 957-2983
Public enquiries
613-957-2991
1-866-225-0709
What Health Canada is doing
Health Canada is continuing to monitor this situation. If the Department is made aware of ongoing sales of products whose licences have been suspended, it will consider taking further action as warranted.