Device product
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.
Z-0649-2016
Product summary
- Event
- Event 72925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16,206 vials total (7,827 vials in US)
- Official record key
device-enforcement:Z-0649-2016
Official wording
Reason: Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.
Code information: 510033A, expiration 2015-03 510034A, expiration 2015-04 510035A, expiration 2015-07 510035B, expiration 2015-09
Distribution pattern: 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.
Derived failure modes
-
Unknown
Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.