Beckman Coulter IQ200 Hematology Analyzers Recalled for Check Valve Defect
Beckman Coulter is recalling IQ200 SPRINT, SELECT, and ELITE hematology analyzers because a check valve defect may cause fluid leaks, creating slip, chemical, and biohazard risks.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes potential physical, chemical, and biohazardous hazards including slip/fall and fluid exposure, but does not report any illnesses, injuries, or deaths.
Plain-English summary
Beckman Coulter, Inc. is recalling IQ200 SPRINT, IQ200 SELECT, and IQ200 ELITE hematology analyzers. The recall involves specific reference numbers and all serial numbers for these models. The devices were distributed worldwide, including across the United States and numerous international countries.
The recall is due to a defect in the rinse-line check valve, which has a shorter service lifespan than originally expected. The check valve requires annual replacement to prevent lamina fluid leakage, but this replacement was excluded from the annual preventive maintenance requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor.
These leaks can result in exposure to physical hazards such as slip and fall risks, chemical hazards from lamina fluid exposure, biohazardous exposure, property damage, and delayed patient results. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B48999, C10683
- 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 (3)
- Product/UDI-DI: IQ200 SPRINT/10837461001256
- IQ200 SELECT/10837461001300
- IQ200 ELITE/10837461001355. All Serial Numbers
Distribution
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