Recall Z-0512-2012
Teco Diagnostics · initiated October 14, 2011
Product
Urine Reagent Strips (URS) 11 Parameters URS-11-100G-001 510(K) number: K970250 Devise Listing number: D072377 Each Device consists of 100 strips of Urine Reagent Strips 11 parameters packed with a desiccant pouch inside a black bottle with Cortez Diagnostics Label on the bottle and the bottle placed inside a Cortez Diagnostics Box.
Codes / lots: Product # 2: URS-II-I00G-00I i. Lot Number: 35224 ii. Expiration Date: 08/2013
Reason for recall
This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134, Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets. Sampling size submitted for QC testing was insufficient based upon number o
FDA-determined cause: Nonconforming Material/Component
Action taken
Teco Diagnostics sent an "URGENT: MEDICAL DEVICE RECALL" letter dated October 14, 2011 to affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed customers to examine their inventory for the affected product and to quarantine any product found. A Recall Return Response Form was included with the letter for customers to complete and return. Contact the firm's Technical Support Department at (800) 222-9880 for questions regarding this recall.
Details
- Recall number
- Z-0512-2012
- Initiated
- October 14, 2011
- Posted by FDA
- January 11, 2012
- Terminated
- April 9, 2013
- Product code
- KQO – Automated Urinalysis System
- Distribution
- Distributed in CA and Poland.
- Recalling firm
- Teco Diagnostics, Anaheim, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0511-2012 | Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise…This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has… | 10/14/2011Terminated |