FDAFDA · Food and drugs·Recall number Z-1255-2019
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
Published May 8, 2019 · Recall initiated: April 3, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The target values and ranges in these lots are incorrect.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Randox Laboratories Ltd.
- Distributor
- The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.
- Lot
- Lot Numbers: 676PD 701PD 716PD
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Ireland
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