iChem 10 SG Urine Chemistry Strips recall
iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific…
Why was iChem 10 SG Urine Chemistry Strips recalled?
Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
510033A, expiration 2015-03 510034A, expiration 2015-04 510035A, expiration 2015-07 510035B, expiration 2015-09
- Product
- iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific…
- Recalling firm
- Beckman Coulter Inc.
- 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.
- Recall date
- January 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)