Beckman Coulter Laboratory Reagents Recalled for Temperature-Related Effectiveness Loss
Beckman Coulter diagnostic reagents used in blood analysis systems were recalled after exposure to temperature excursions during storage and shipment. Products received between June and September 2021 may have reduced effectiveness.
What this means for you
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: This is an FDA Class II medical device recall. Although no illnesses or injuries have been reported, the recalled products are critical diagnostic reagents where loss of effectiveness could result in inaccurate test results and potentially affect patient care decisions.
Plain-English summary
Beckman Coulter, Inc. has recalled multiple diagnostic reagent products used in automated blood-analysis systems. The recalled products include Coulter DxH Diff Pack, DxH Cleaner, DxH 500 Series Lyse, and DxH 500 Series Cleaner reagents.
The products were affected by temperature excursions that occurred at the distributor's facility between June and August 2021, prior to shipment to end users. Exposure to elevated temperatures may have impacted the effectiveness of the reagents, potentially affecting the accuracy of test results.
All product lots received between June 1, 2021, and September 30, 2021, are included in the recall. The products were distributed nationwide in the United States.
Healthcare facilities and laboratories currently holding or using affected products should discontinue use and contact McKesson Medical-Surgical Inc. to arrange return or replacement of the recalled reagents.
The recalled product
- Product
- BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Serie
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- product-degradation
- effectiveness-loss
Distribution
Distributed nationwide across the United States.
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