Recall Z-2353-2008 ยท FKP System, Dialysate Delivery, Single Patient
Hach Co
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
| Date | Sep 21, 2008 (initiated May 23, 2008) |
| Status | Terminated |
| Reason | Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results |
| Root 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 custo |
| Quantity | 21,540 bottles |
| Distribution | Nationwide and Foreign distribution to Canada and Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003615 | STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS Environmental Test Systems, Inc., Feb 1, 2001 |