Recall Z-1254-2019
Randox Laboratories Ltd. · initiated April 3, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
Codes / lots: Lot Numbers: 687PD 700PD 715PD
Reason for recall
The target values and ranges in these lots are incorrect.
FDA-determined cause: Nonconforming Material/Component
Action taken
Randox sent an Urgent Medical Device Correction notification letters dated 4/2/19 to affected customers. The letter identified the affected product, problem and action to be taken: " Discontinue use of and quarantine any of the above devices immediately. " Discuss the contents of this notice with your Medical Director. " Review results generated with the affected batches in line with the clinical profile of the patient. " Inform all relevant staff members. If you have supplied or transferred any potentially affected product to another facility or organization, let that facility know of the recall immediately by providing a copy of this FSN and response form. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. For questions contact Randox Technical Services.
Details
- Recall number
- Z-1254-2019
- Initiated
- April 3, 2019
- Terminated
- October 9, 2019
- Product code
- JBL – Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
- Quantity
- 14 kits
- Distribution
- The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1255-2019 Class II | G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This…The target values and ranges in these lots are incorrect. | 04/03/2019Terminated |