Recall Z-2634-2010 ยท LJX Test, Urine Leukocyte
ARKRAY USA INC.
Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400.
| Date | Sep 30, 2010 (initiated Mar 24, 2010) |
| Status | Terminated |
| 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 |
| Quantity | 5504 |
| Distribution | FL, NJ, MI, NV, FL, OH, GA, WI, NY, KY, LA, CA, CT, TN, IL ISRAEL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981555 | DIASCREEN REAGENT STRIPS Chronimed, Inc., Jun 1, 1998 |