Z-0649-2016Class II

iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein...

Name: Z-0649-2016 iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein...
Creator: Beckman Coulter Inc.
Published: 2014-12-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-12-08 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity... on 2014-12-08. FDA classified it as Class II and gives the reason as "Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0649-2016
Classification: Class II
Status: Terminated
Initiated: 2014-12-08
Posted: 2016-01-13
Terminated: 2016-01-13
Recalling firm: Siemens Healthcare Diagnostics 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.
Product code: JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 510033A, expiration 2015-03 510034A, expiration 2015-04 510035A, expiration 2015-07 510035B, expiration 2015-09

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0649-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0649-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-13

Product code JIL

K060280Class IIIchem 100 Urine Chemistry AnalyzerIris International, Inc. / cleared 2006-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)