G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
Reported: May 8, 2019 Initiated: April 3, 2019 #Z-1255-2019
Product Description
G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
Reason for Recall
The target values and ranges in these lots are incorrect.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 10 kits
- Distribution
- The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes. Recalled by Randox Laboratories Ltd.. Units affected: 10 kits.
Why was this product recalled? ▼
The target values and ranges in these lots are incorrect.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2019. Severity: Moderate. Recall number: Z-1255-2019.
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