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Open, Classified

Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.

FDA Recall Z-1547-2020 · Posted None

Recalling FirmRandox Laboratories Ltd.
Recall StatusOpen, Classified
Product CodeJJY
Date Initiated2020-02-18
Product Quantity186 total, 27 USA

Reason for Recall

The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.

Firm Action

On February 18, 2020, the firm notified customers of the action via emailed Urgent Medical Device Correction letters. Customers were informed of the incorrectly assigned control target and range value for Sodium using the ISE indirect method. The letter stated that the sections for Roche Cobas series and mean of all instruments has now been updated, and the updated value sheets were included with the email. The updated value sheets may also be found on www.randox.com. Customers were asked to take the following actions: - Review results generated with the affected batches in line with the clinical profile of the patient. -Discuss the contents of the notice with your Medical Director. -Complete and return the included response form within 5 working days. Distributors were asked to forward a copy of the notice to all affected customers. If you have questions or concerns, please contact Randox Technical Services: 866-4-RANDOX, or [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of WV, IN, VA, ID, PR, DE, and countries of West Indies, Czech Republic, France, Germany, Hong Kong, Ireland, Italy, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan (R.O.C.), Thailand, UAE, UK.

Official Source

View FDA Recall →

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

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