| Class 3 Device Recall Urine Specimen Collection Kit |  |
Date Initiated by Firm | April 17, 2014 |
Date Posted | June 14, 2014 |
Recall Status1 |
Terminated 3 on August 26, 2014 |
Recall Number | Z-1793-2014 |
Recall Event ID |
68229 |
510(K)Number | K003395 |
Product Classification |
Urine collection kit (excludes hiv testing) - Product Code OIE
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Product | APTIMA Urine Collection Kit; Catalog Number
301040, Lots 27231, 27232, 27233, and 27234.
Product Usage: The 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. |
Code Information |
Catalog #301040. Lot Numbers: 27231, 27232, 27233, 27234. Expriation Date: 31JAN2015. |
Recalling Firm/ Manufacturer |
Gen-Probe Inc 10210 Genetic Center Dr San Diego CA 92121-4362
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For Additional Information Contact | 858-731-5835 |
Manufacturer Reason for Recall | 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." |
FDA Determined Cause 2 | Labeling mix-ups |
Action | Hologic sent a Recall Notice letter dated April 14, 2014 via overnight mail (FedEx) to affected customers. The letter identified the affected product, problem and actions to be taken. The notification letter requests customers to: 1. segregate the entire contents of the affected kit lots
2. reconcile and destroy all partial and/or full kits remaining in inventory and to document; the amount destroyed on the Customer Response Form provided with the Recall Notice; 3. if the urine collection kits were further distributed to other collection sites, then to notify them of this issue; and 4. complete and return the Customer Response Form to Technical Support (contact information is provided in the notification letter).
For additional information, questions, or concerns, contact Hologic Molecular (Technical) Support.
Toll Free: 888-484-4747
Direct: 858-410-8511
Fax: 858-410-8250
Email: molecularsupport@hologic.com |
Quantity in Commerce | 4,740 units |
Distribution | Worldwide Distribution - US Nationwide and the countries of Canada (CA), Denmark (DK), France (FR), Germany (DE), and the United States (US), Belgium (BE), United Kingdom (GB). |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = OIE
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