FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0649-2016
- Recalling firm
- Beckman Coulter Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-12-08
- Posted
- not on file
- Terminated
- 2016-01-13
- 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 Customer Service Support or complete and return the Replacement Order form, if replacement product is needed. The enclosed response form should be completed and returned within 10 days. Customers with questions are instructed to refer to http://www.beckmancoulter.com; (800) 854-3633 in US and Canada. Customers outside the US and Canada are instructed to contact their local support representative.
- 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.
- Lot, serial or model codes
- 510033A, expiration 2015-03 510034A, expiration 2015-04 510035A, expiration 2015-07 510035B, expiration 2015-09
- 510(k) numbers
- ["K060280"]
- PMA numbers
- not on file
- Product code
- JIL
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- 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