Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise Listing number: D072377 Each device c

FDA device recall Z-0511-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Teco Diagnostics

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 (Refer to next paragraph). Sampling size submitted for QC testing was insuff

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KQO

Quantity affected

550 kits

Distribution

Distributed in CA and Poland.

Date initiated

2011-10-14

Date posted

2012-01-11

Date terminated

2013-04-09

Location

Anaheim, CA