Z-2016-2009

HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part...

Name: Z-2016-2009 HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part...
Creator: Hach Co
Published: 2009-04-21
License: https://open.fda.gov/license/

Hach Company / initiated 2009-04-21 / Terminated / root cause: labeling and UDI

FDA source

Hach Co began a recall of HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part #1905LB, Hach Co., Ames, IA. SteriChek Residual... on 2009-04-21. The reason FDA records is "Some of the reagent strip bottles contain the incorrect strips". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2016-2009
Status: Terminated
Initiated: 2009-04-21
Posted: 2009-09-04
Terminated: 2009-10-07
Recalling firm: Hach Company
Product: 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.
Product code: LIF Dialyzer Reprocessing System
Reason for recall: Some of the reagent strip bottles contain the incorrect strips
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Hach Company issued an "Urgent Medical Device Recall" letter dated April 21, 2009 explaining the reason for recall and requested product remaining in inventory be returned. Subrecall to the end-user level was requested. A Return Form was also enclosed to be completed to indicate the amount of product being returned. Between April 22-23, 2009, the firm telephoned their customers to assure they received the recall letter. For further information, contact Hach Customer Service at 1-800-548-4381 extension 3560.
Quantity in commerce: 275 kits
Distribution: Nationwide Distribution -- NJ, CA, IN, PA, NV, CA, and ME.
Product codes and lots: Part Number: 811905, Lot Number: A8350; and Part Number: 1905LB, Lot Numbers: 8350 and 8345.

Product code LIF

K974798Class IISterichek(tm) Residual Peroxide Reagent StrpsEnvironmental Test Systems, Inc. / cleared 1998-03-20

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)