Reported Jun 25, 2014 · Terminated
APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA…
Gen-Probe Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Gen-Probe Inc · 10210 Genetic Center Dr · San Diego, CA · 92121-4362
Is this the product you have?
APTIMA Urine Collection KitCatalog Number 301040Lots 272312723227233and 27234
- Product UsageThe APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens
- Lot codes and dates
- Catalog #301040
- Lot Numbers
27231272322723327234
- Expriation Date31JAN2015
- Amount recalled
- 4,740 units
Where it was sold
Why it was recalled
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 Collection Kits"; however, the inner pouches are incorrectly labeled as "APTIMA Unisex Swab Collection Kit for Endocervical and Male Urethral Swab Specimens."
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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