Recall Z-0649-2016 ยท JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Beckman Coulter Inc.
iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
| Date | Dec 8, 2014 |
| Status | Terminated |
| Reason | Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative. |
| Root cause | Nonconforming Material/Component |
| Action | An "Important Product Notice," dated 12/8/14 was sent to customers to inform them of the recall by Iris International. The recall letter informs customers that The identified lots of iChem 10 SG Urine Chemistry Strips may have leukocyte pads that are more sensitive at the first reporting range of 1+, corresponding to 25 white blood cells (WBCs) /microliter. The letter provides the impact of the recall and the actions to taken by the customers. Customers are instructed to discard any remaining strips from the affected lots and use another lot number. Customers can either contact their local |
| Quantity | 16,206 vials total (7,827 vials in US) |
| Distribution | Worldwide Distribution -- US, Brazil, Canada, Chile, Ecuador, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Philippines, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Turkey, and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060280 | ICHEM 100 URINE CHEMISTRY ANALYZER Iris International, Inc., Jun 13, 2006 |