Bicarbonate reagent recalled over falsely high results from LDH interference
Beckman Coulter is recalling 36,981 bicarbonate reagents because they may generate falsely high bicarbonate results due to interference with lactate dehydrogenase in the sample.
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: Scored 3 under the risk-of-harm criterion: the firm states the reagent may generate falsely high results, and no injuries are reported.
Plain-English summary
Beckman Coulter Bicarbonate, REF OSR6137, OSR6237 and OSR6637, a system reagent for the quantitative determination of bicarbonate in human serum and plasma on Beckman Coulter AU analyzers, is being recalled by Beckman Coulter Ireland, Inc.
The bicarbonate reagent may generate falsely high bicarbonate results due to interference with lactate dehydrogenase (LDH) in the test sample.
The record lists 36,981 reagents, of which 35,320 are in the United States and 1,661 outside it, with catalog numbers and UDI-DI codes listed in the enforcement record including OSR6137 under 15099590020187 across lots 2681 to 2688 among others. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
A falsely high result can affect the clinical decisions made from it. The enforcement record reports no injuries. Laboratories should follow Beckman Coulter's instructions.
The recalled product
- Product
- BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
- Manufacturer
- Beckman Coulter Ireland, Inc.
Distribution
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