Class 2 Device Recall HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Product 811909

• Date Initiated by Firm: May 23, 2008
• Date Posted: September 21, 2008
• Recall Status: Terminated on March 20, 2012
• Recall Number: Z-2352-2008
• Recall Event ID: 48613
• 510(K)Number: K003615
• Product Classification: Reagent strips - Product Code FKP
• Product: HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bottles containing 100 strips each, 5 bottles per kit, Part #811909. The firm name on the label is Hach, Ames, IA. The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.
• Code Information: Lot numbers 6248, 6254, 6264, 6266, 6280, 6305, 6312, 6317, 6334, 6347, 6353, 6355, 7002, 7012, 7015, 7031, 7044, 7066, 7072, 7073, 7085, 7094, 7121, 7131, 7049, 7150, 7152, 7163, 7167, 7177, 7295, 7296, 7309, 7325, 7340, 7352, 7355, 8028, 8045, 8066, 8084, 8094, 8106, 8123, 8144, 8155, 8166, 8171, 7179, 7200, 7220, 7236, 7239, 7250, and 7282
• Recalling Firm/ Manufacturer: Hach Co; 100 Dayton Ave; Ames IA 50010-6402
• For Additional Information Contact: Colleen Boswell; 714-516-7484
• Manufacturer Reason for Recall: Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm initiated phone calls on 5/22/08 and explained the reason for recall and requested the product be quarantined. The customer was informed they would receive a recall letter providing instructions for return, replacement, or credit. During the phone call, some of the customers asked if they should recall to the end user level and they were told to do so, but this instruction was not verbally given to everyone. The recalling firm issued a letter dated 5/23/08 via overnight mail which explained the reason for recall and requested return of the product. The letter requests the customer to notify the end users. A Return Form was enclosed to report the amount of product being returned. The firm telephoned all nonresponders on 7/1-2/08 to assure they received the recall notification. On 7/21/08, the firm issued two different letters flagged as "Expanded Recall Notification" dated 7/21/08. One of the letters covered Product/Part numbers 811909, 812144, and 821972, which were all HACH brands. The other letter covered Product/Part number 812004, which was a private brand. Reason for recall expansion was explained and return of product was requested. If the product was further distributed, subrecall was requested to the end user level. A "Return Form" was enclosed to be completed to indicate the amount of product being returned. Some customers who tried to order product #811909 received a letter dated 7/28/08 informing them they could use their Total Chlorine DPD Test Kit, product #811902, as an alternative method for testing. For assistance, contact Hach Customer Service at 1-800-548-4381, ext. 3563.
• Quantity in Commerce: 80,110 bottles
• Distribution: Nationwide and Foreign distribution to Canada and Denmark.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = FKP and Original Applicant = ENVIRONMENTAL TEST SYSTEMS, INC.