UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
Reported: December 20, 2017 Initiated: November 3, 2017 #Z-0237-2018
Product Description
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
Reason for Recall
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 1 unit
- Distribution
- CA, AR, HI, CA, OH, WA, MD, Canada, Japan
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities). Recalled by Beckman Coulter Inc.. Units affected: 1 unit.
Why was this product recalled? ▼
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 20, 2017. Severity: Moderate. Recall number: Z-0237-2018.
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