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Terminated

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

FDA Recall Z-1255-2019 · Posted None

Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeJBL
Date Initiated2019-04-03
Date Terminated2019-10-09
Product Quantity10 kits

Reason for Recall

The target values and ranges in these lots are incorrect.

Firm Action

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 [email protected] within five working days. For questions contact Randox Technical Services.

Root Cause

Nonconforming Material/Component

Distribution Pattern

The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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