Beckman Coulter Inc.: Medical Device Recall in 2016 - (Recall #: Z-0649-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 8, 2014

Date Posted: January 20, 2016

Recall Number: Z-0649-2016

Event ID: 72925

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.

Status: Terminated

Product Quantity: 16,206 vials total (7,827 vials in US)

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.

Voluntary or Mandated:

Voluntary: Firm initiated