Z-2355-2008

HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, tests for feed water and...

Name: Z-2355-2008 HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, tests for feed water and...
Creator: Hach Co
Published: 2008-05-23
License: https://open.fda.gov/license/

Hach Company / initiated 2008-05-23 / Terminated / root cause: manufacturing process

FDA source

Hach Co began a recall of 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... on 2008-05-23. The reason FDA records is "Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2355-2008
Status: Terminated
Initiated: 2008-05-23
Posted: 2008-09-21
Terminated: 2012-03-20
Recalling firm: Hach Company
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 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.
Product code: FKP System, Dialysate Delivery, Single Patient
Reason for recall: Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results
Root cause tag: manufacturing process
FDA 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 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: 26,040 bottles
Distribution: Nationwide and Foreign distribution to Canada and Denmark.
Product codes and lots: Lot numbers 7264, 7267, 7268, 7270, 7344, 7360, 7362, 8085, 8128, 8152, 8164, and 8173

Product code FKP

K003615Class IISterichek Sensitive-Feed Water and Rinse Water Reagent StripsEnvironmental Test Systems, Inc. / cleared 2001-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)