UIBC assay does not meet its labeled hemoglobin interference claim
The Unsaturated Iron Binding Capacity assay is being recalled because it is not meeting the labeled hemoglobin interference claims stated in its instructions for use. 56,696 units affected.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: an assay that does not perform within its stated interference limits, affecting patient results, with no harm reported in the source.
Plain-English summary
The UIBC (Unsaturated Iron Binding Capacity) assay, REF OSR61205, UDI 15099590011925, is being recalled across all lots. The action covers 56,696 units.
According to Beckman Coulter, the UIBC assay is not meeting the labeled hemoglobin interference claims of no significant interference, meaning less than 10%, up to 200 mg/dL hemoglobin as indicated in the instructions for use. Initial internal testing confirmed the issue in samples with low UIBC levels. The FDA classified the action as Class II. The source does not report any patient harm having occurred.
Distribution was in Alaska, Alabama, Arkansas, Colorado, Connecticut, the District of Columbia, Delaware, Idaho and Utah in the United States, and internationally to Algeria, Argentina, Australia and Bahrain among other countries.
Laboratories should identify affected stock using the REF and UDI above and follow the instructions issued by Beckman Coulter.
The recalled product
- Product
- UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 56,696
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 (1)
- All Lots/(01)15099590011925
Distribution
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