FDA Medical Device Recalls (openFDA)
Teco Diagnostics: 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 number
- Z-0511-2012
- Recalling firm
- Teco Diagnostics
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-10-14
- Posted
- 2012-01-11
- Terminated
- 2013-04-09
- Reason
- 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
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 550 kits
- Distribution
- Distributed in CA and Poland.
- Lot, serial or model codes
- Product/Catalog # 1: URS-l 0-100W i. Lot Number: 35264 ii. Expiration Date: 01/2014
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KQO
- Firm FEI
- 1832216
- Firm city
- Anaheim
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28