FDA Medical Device Recalls (openFDA)
ARKRAY USA INC.: Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400.
- Recall number
- Z-2634-2010
- Recalling firm
- ARKRAY USA INC.
- Product
- Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400.
- Status
- Terminated
- Initiated
- 2010-03-24
- Posted
- 2010-09-30
- Terminated
- 2012-03-08
- Reason
- 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
- 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
- 5504
- Distribution
- FL, NJ, MI, NV, FL, OH, GA, WI, NY, KY, LA, CA, CT, TN, IL ISRAEL
- Lot, serial or model codes
- 03269A, 06089A, 10079A and 11099A
- 510(k) numbers
- ["K981555"]
- PMA numbers
- not on file
- Product code
- LJX
- Firm FEI
- 1832816
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28