Hematology analyzers recalled over erroneously high hemoglobin results in some samples
UniCel DxH 690T Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice states the analyzer can produce erroneously high patient results and no injuries are reported.
Plain-English summary
The UniCel DxH 690T COULTER Cellular Analysis System configured with the LED HGB Photometer, REF C34520, UDI 15099590729110, is being recalled. Affected serial numbers include BD17734, BE12048, BE28105, BF14045, BF23096, BF46236, BG26135 and BG50247, with the full list in the recall notice. Distribution was nationwide in the United States and internationally.
Hematology analyzers configured with HGB photometers may produce erroneously high hemoglobin results on samples with elevated white blood cell counts. The FDA classified the action as Class II.
Laboratories operating these analyzers should follow the manufacturer's instructions, including any guidance on reviewing results already reported.
The recalled product
- Product
- UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
- 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 (10)
- UDI: 15099590729110/ Serial Numbers: BD17734
- BE12048
- BE28105
- BF14045
- BF23096
- BF46236
- BG26135
- BG50247
- BH12019
- BH43168
Distribution
Part of a larger recall action
This product is one of 4 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.
See all 4 products in this recall →Related recalls
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