Beckman Coulter Recalls iChem 10 SG Urine Chemistry Strips
Beckman Coulter is recalling iChem 10 SG Urine Chemistry Strips because they may produce false positive leukocyte results for negative samples.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves inaccurate test results (false positives) rather than direct physical injury or contamination, fitting the criteria for moderate severity involving labeling or performance errors without reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling the iChem 10 SG Urine Chemistry Strips (PN 800-7005). The recall involves 16,206 vials total, with 7,827 vials distributed in the United States. The product is intended for the in vitro measurement of various urine chemistry parameters, including leukocyte esterase.
The recall is being conducted because the strips may produce false positive leukocyte results for samples that are truly negative. This defect could lead to incorrect clinical interpretations of urine test results.
The affected lots are identified by the following codes and expiration dates: 510033A (expiration 2015-03), 510034A (expiration 2015-04), 510035A (expiration 2015-07), and 510035B (expiration 2015-09). The product was distributed worldwide, including in the US, Brazil, Canada, Chile, Ecuador, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Philippines, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Turkey, and the United Arab Emirates.
The recalled product
- 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.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 510033A
- expiration 2015-03 510034A
- expiration 2015-04 510035A
- expiration 2015-07 510035B
- expiration 2015-09
Distribution
Distributed in 1 state:
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