Events

Rappel de Device Recall HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Product 812144

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Hach Co.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    48613
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2355-2008
  • Date de mise en oeuvre de l'événement
    2008-05-23
  • Date de publication de l'événement
    2008-09-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72687
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Reagent strips - Product Code FKP
  • Cause
    Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results.
  • 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.

Device

Device Recall HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, P...
  • Modèle / numéro de série
    Lot numbers 7264, 7267, 7268, 7270, 7344, 7360, 7362, 8085, 8128, 8152, 8164, and 8173
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Foreign distribution to Canada and Denmark.
  • Description du dispositif
    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.
  • Manufacturer
    Hach Co

Manufacturer

Hach Co
  • Adresse du fabricant
    Hach Co, 100 Dayton Ave, Ames IA 50010-6402
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA