Z-2634-2010

Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400

Name: Z-2634-2010 Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400
Creator: Arkray USA Inc.
Published: 2010-03-24
License: https://open.fda.gov/license/

Arkray Factory USA, Inc. / initiated 2010-03-24 / Terminated / root cause: labeling and UDI

FDA source

ARKRAY USA INC. began a recall of Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400 on 2010-03-24. The reason FDA records is "This recall has been initiated due to a labeling issue with the Hypoguard DiaScreen 4-way pH 100 strips. The front and back panel of the bottle carton lists five reagents when it should only list four reagents. The...". 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-2634-2010
Status: Terminated
Initiated: 2010-03-24
Posted: 2010-09-30
Terminated: 2012-03-08
Recalling firm: Arkray Factory USA, Inc.
Product: Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400.
Product code: LJX Test, Urine Leukocyte
Reason for recall: This recall has been initiated due to a labeling issue with the Hypoguard DiaScreen 4-way pH 100 strips. The front and back panel of the bottle carton lists five reagents when it should only list four reagents. The Ketone reagent should not be included on the label. The test strips contained in the bottle and all other labeling are correct and properly align with 4pH part number D11400 listed on
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Distributors were sent a Arkray "URGENT: Voluntary Medical Device RECALL " letter dated March 24, 2010. The letter described the problem and the product being recalled. The letter requested the distributors to immediately examine their inventory , quarantine and return the product subject to the recall. If the distributors had further distributed the recalled product, then they were requested to notify the customers of the recall. Arkray enclosed a customer recall letter that the distributors were to use for notifying their customers. Distributors were also contacted by phone on March 24, 2010, and were informed of the recall issue, the product involved, instructed to quarantine the product and to notify their customers.
Quantity in commerce: 5504
Distribution: FL, NJ, MI, NV, FL, OH, GA, WI, NY, KY, LA, CA, CT, TN, IL ISRAEL
Product codes and lots: 03269A, 06089A, 10079A and 11099A

Product code LJX

K981555Class IDiascreen Reagent StripsChronimed, Inc. / cleared 1998-06-01

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)