Beckman Coulter Recalls DxH Diluent Due to Hemoglobin Chamber Compromise
Beckman Coulter is recalling specific lots of COULTER DxH Diluent because increased complaints indicate the product may compromise the hemoglobin chamber in certain blood analysis 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 where the hazard is a compromised hemoglobin chamber, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling specific lots of COULTER DxH Diluent (Catalog No. 628017, Part No. A59956). This product is an isotonic buffered diluent used with a cyanide-free lytic agent for counting and sizing blood cells on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.
The recall was initiated after the company received an increased number of complaints related to Hemoglobin (HGB) readings on these systems. The use of the affected diluent lots may eventually result in a compromised HGB chamber. The recall covers 829,888 units total, with 659,584 units distributed in the United States. The affected lots are numbered 3099980 through 3512190, with expiration dates ranging from 17 April 2015 to 26 August 2016.
The product was distributed worldwide, including in the United States, Puerto Rico, Canada, and various countries in South America, Asia, and the Middle East. Healthcare facilities and laboratories using these specific systems and diluent lots should stop using the affected product and contact Beckman Coulter for further instructions.
The recalled product
- Product
- COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.
- Manufacturer
- Beckman Coulter Inc.
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 (2)
- Lot No. 3099980 - 3512190
- expiration dates: 17 April 2015 - 26 August 2016.
Distribution
Distributed in 1 state:
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