Beckman Coulter Recalls Isoton 4 Diluent for Hematology Systems
Beckman Coulter is recalling specific lots of Isoton 4 Diluent because they may compromise the Hgb cuvette in LH 750 and LH780 Hematology Systems.
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: The recall involves a medical device component that may compromise testing equipment, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling 710 units of COULTER ISOTON 4 Diluent, Catalog No. 8547148. The affected lot numbers are 18203F through 18206F. This diluent is used in LH 750 and LH780 Hematology Systems to analyze blood samples for different cell types, such as red blood cells and platelets.
The recall was initiated because the use of these specific diluent lots may eventually result in a compromised Hgb cuvette. The product was distributed nationwide in the United States, including Puerto Rico and the U.S. Virgin Islands, as well as in Bermuda, Canada, Guatemala, Hong Kong, Mexico, Panama, Taiwan, and Trinidad-Tobago.
Users of the affected hematology systems should check their inventory for the listed lot numbers and stop using the product if it matches. Beckman Coulter is the recalling firm responsible for this action.
The recalled product
- Product
- COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 710
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)
- Lot Numbers: 18203F-18206F.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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