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PlaySafe™
RANDOX LABORATORIES LIMITED · Model SCK10690 · UDI-DI 05055273220018
0
510(k) clearances
10
Adverse events
1
Recalls
47
Facilities
Description
The PlaySafe kit is intended for use in the collection of a urine sample for laboratory analysis of nine sexually transmitted infections: (Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex virus I, Herpes simplex virus II, Trichomonas vaginalis, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum & Haemophilus ducreyi (chancroid). This device is intended for sample collection purpose only. Samples may be collected at home through adherence to the Instructions for Use (IFU) document or may be collected under the guidance of a medical professional.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-04-17 | Gen-Probe Inc | Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collect |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.