Calibration Serum Level 3 CAL2351
Reported: January 24, 2024 Initiated: November 20, 2023 #Z-0752-2024
Product Description
Calibration Serum Level 3 CAL2351
Reason for Recall
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 269 kits
- Distribution
- US Nationwide and Puerto Rico.
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
Calibration Serum Level 3 CAL2351. Recalled by Randox Laboratories Ltd.. Units affected: 269 kits.
Why was this product recalled? ▼
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2024. Severity: Moderate. Recall number: Z-0752-2024.
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