Hach Company
Ames, IA, US
HACH COMPANY appears in FDA device records in Ames, IA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Hach Company in 2017.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1833407 | 1000518597 | HACH COMPANY | 100 DAYTON AVE., AMES, IA 50010 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2016-2009 | HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part #1905LB, Hach Co., Ames, IA. SteriChek Residual Peroxide Reagent Strips provide a convenient means of measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid. | Some of the reagent strip bottles contain the incorrect strips | Terminated | ||
| Z-2355-2008 | 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 bags containing 1/100-strip bottle, one medicine cup, and one insert. Each bag is sealed and labeled "812144 SteriChek Sensitive, Bagged, " 56 bags per cardboard tray, 5 trays per shipping case. Product code 812144 The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate. | Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results | Terminated | ||
| Z-2354-2008 | RPC E-Z Chek Sensitive Total Chlorine and Chloramines Test Strips, Tests Water for Total Chlorine & Chloramines down to 0.1 ppm (mg/l), packaged in a 1/100-strip bottle, 60 bottles per tray, 5 trays per shipping case, Product code K100-0106 (HACH Part #812004). The label shows the product is Manufactured for Reprocessing Products Corp. (RPC), Minneapolis, MN. The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate. | Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results | Terminated | ||
| Z-2353-2008 | HACH SteriChek Sensitive Total Chlorine Reagent Strips, Tests for water and rinse water down to 0.1 mg/l (ppm), packaged 1/100-strip btl. per carton, 12 cartons per shipping case, Product #821972. The firm name on the label is HACH Company, 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. | Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results | Terminated | ||
| Z-2352-2008 | 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. | Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain