Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise Listing number: D072377 Each device consists of 100 strips of Urine Reagent Strips 10 parameters packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label on the bottle and the bottle placed inside a Teco Diagnostics Box. For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine.
Recall
- Recall Number
- Z-0511-2012
- Event Number
- 60476
- Firm
- Teco Diagnostics
- FEI Number
- 1832216
- Product Code
- KQO
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 14, 2011
- Posted
- January 11, 2012
- Terminated
- April 9, 2013
- Address
- 1268 N Lakeview Ave, Anaheim, CA, 92807-1831
Description
Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise Listing number: D072377 Each device consists of 100 strips of Urine Reagent Strips 10 parameters packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label on the bottle and the bottle placed inside a Teco Diagnostics Box. For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine.
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 (Refer to next paragraph). Sampling size submitted for QC testing was insuff
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.
Distributed in CA and Poland.
550 kits